Pantoprazol (pantoprazole sodium)

Para qué se usa Pantoprazol

Cita de la sección «Indications and Usage» (indicaciones y uso) de la etiqueta aprobada por la FDA. Se muestra en inglés, tal como la publica la FDA.

PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX is a proton pump inhibitor (PPI) indicated for the following: • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) • Maintenance of Healing of Erosive Esophagitis • Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome 1.1 Short-Term …

— Etiqueta de la FDA: Protonix Delayed-Release, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., vigente desde el 18 de mayo de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (tablet, delayed release, oral), Protonix Delayed-Release, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.; abarca 3 productos del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.

La FDA tiene 132 etiquetas para productos de este medicamento (distintos fabricantes y presentaciones); los usos pueden variar. Revise la etiqueta de su propio medicamento.

Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.

Enfermedades que menciona la etiqueta

Estos nombres aparecen tal cual en la sección «Indications and Usage» de la etiqueta (según una tabla revisada). Cada página muestra los hospitales cuyos sitios web mencionan la enfermedad.

Especialidades médicas relacionadas

Advertencia en recuadro

La advertencia en recuadro («caja negra») es la advertencia más seria de la FDA en la etiqueta de un medicamento, para riesgos graves o mortales.

La etiqueta citada arriba no tiene advertencia en recuadro.

4 de 132 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.

Efectos secundarios de Pantoprazol

Cita de la sección «Adverse Reactions» (reacciones adversas) de la etiqueta aprobada por la FDA. Se muestra en inglés. Avise a su médico de cualquier efecto secundario que le preocupe.

The following serious adverse reactions are described below and elsewhere in labeling:

• Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)]
• Clostridium difficile- Associated Diarrhea [see Warnings and Precautions (5.3)]
• Bone Fracture [see Warnings and Precautions (5.4)]
• Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5)]
• Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6)]
• Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.7)]
• Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.8)]
• Fundic Gland Polyps [see Warnings and Precautions (5.10)] Most common adverse reactions are:
• For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.

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(6.1)

• For pediatric use (>4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The adverse reaction profiles for PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets are similar. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adults Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral PROTONIX (20 mg or 40 mg), 299 patients on an H 2 -receptor antagonist, 46 patients on another PPI, and 82 patients on placebo. The most frequently occurring adverse reactions are listed in Table 3. Table 3: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of >2% PROTONIX (n=1473) % Comparators (n=345) % Placebo (n=82) % Headache 12.2 12.8 8.5 Diarrhea 8.8 9.6 4.9 Nausea 7.0 5.2 9.8 Abdominal pain 6.2 4.1 6.1 Vomiting 4.3 3.5 2.4 Flatulence 3.9 2.9 3.7 Dizziness 3.0 2.9 1.2 Arthralgia 2.8 1.4 1.2 Additional adverse reactions that were reported for PROTONIX in clinical trials with a frequency of ≤2% are listed below by body system: Body as a Whole: allergic reaction, pyrexia, photosensitivity reaction, facial edema Gastrointestinal: constipation, dry mouth, hepatitis Hematologic: leukopenia, thrombocytopenia Metabolic/Nutritional: elevated CK (creatine kinase), generalized edema, elevated triglycerides, liver enzymes elevated Musculoskeletal: myalgia Nervous: depression, vertigo Skin and Appendages: urticaria, rash, pruritus Special Senses: blurred vision Pediatric Patients Safety of PROTONIX in the treatment of EE associated with GERD was evaluated in pediatric patients ages 1 year through 16 years in three clinical trials. Safety trials involved pediatric patients with EE; however, as EE is uncommon in the pediatric population, 249 pediatric patients with endoscopically-proven or symptomatic GERD were also evaluated. All adult adverse reactions to PROTONIX are considered relevant to pediatric patients. In patients ages 1 year through 16 years, the most commonly reported (>4%) adverse reactions include: URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. For safety information in patients less than 1 year of age see Use in Specific Populations (8.4).

— Etiqueta de la FDA: Protonix Delayed-Release, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., vigente desde el 18 de mayo de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Pantoprazol

Cita de la sección «Drug Interactions» (interacciones) de la etiqueta aprobada por la FDA. Se muestra en inglés. Dígale a su farmacéutico todos los medicamentos, vitaminas y productos herbales que toma.

Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PROTONIX and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

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Table 4: Clinically Relevant Interactions Affecting Drugs Co-Administered with PROTONIX and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.

• Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with pantoprazole may reduce antiviral effect and promote the development of drug resistance.
• Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with pantoprazole may increase toxicity of the antiretroviral drugs.
• There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole. Intervention: Rilpivirine-containing products: Concomitant use with PROTONIX is contraindicated [see Contraindications (4)]. See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with PROTONIX. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals: See prescribing information. Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin. Clopidogrel Clinical Impact: Concomitant administration of pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition [see Clinical Pharmacology (12.3)]. Intervention: No dose adjustment of clopidogrel is necessary when administered with an approved dose of PROTONIX. Methotrexate Clinical Impact: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions (5.13)]. Intervention: A temporary withdrawal of PROTONIX may be considered in some patients receiving high-dose methotrexate.

— Etiqueta de la FDA: Protonix Delayed-Release, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., vigente desde el 18 de mayo de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Pantoprazol

Cita de la sección «Dosage and Administration» (dosis y administración) de la etiqueta aprobada por la FDA. Se muestra en inglés. Su dosis es la que le receta su médico: no la cambie por su cuenta.

Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD (2.1) Adults 40 mg Once Daily for up to 8 wks Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis (2.1) Adults 40 mg Once Daily Controlled studies did not extend beyond 12 months Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (2.1) Adults 40 mg Twice Daily See full prescribing information for administration instructions 2.1 Recommended Dosing Schedule PROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets.

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The recommended dosages are outlined in Table 1. Table 1: Recommended Dosing Schedule for PROTONIX Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily Controlled studies did not extend beyond 12 months Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered. 2.2 Administration Instructions Directions for method of administration for each dosage form are presented in Table 2. Table 2: Administration Instructions Formulation Route Instructions Do not split, chew, or crush PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension. Delayed-Release Tablets Oral Swallowed whole, with or without food For Delayed-Release Oral Suspension Oral Administered in 1 teaspoonful of applesauce or apple juice approximately 30 minutes prior to a meal For Delayed-Release Oral Suspension Nasogastric tube See instructions below Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time. PROTONIX Delayed-Release Tablets Swallow PROTONIX Delayed-Release Tablets whole, with or without food in the stomach. For patients unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of PROTONIX Delayed-Release Tablets. PROTONIX For Delayed-Release Oral Suspension Administer PROTONIX For Delayed-Release Oral Suspension approximately 30 minutes prior to a meal via oral administration in apple juice or applesauce or nasogastric tube in apple juice only. Because proper pH is necessary for stability, do not administer PROTONIX For Delayed-Release Oral Suspension in liquids other than apple juice, or foods other than applesauce. Do not divide the 40 mg PROTONIX For Delayed-Release Oral Suspension packet to create a 20 mg dosage for pediatric patients who are unable to take the tablet formulation. PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Applesauce

• Open packet.
• Sprinkle granules on one teaspoonful of applesauce. DO NOT USE OTHER FOODS OR CRUSH OR CHEW THE GRANULES.
• Take within 10 minutes of preparation.

— Etiqueta de la FDA: Protonix Delayed-Release, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., vigente desde el 18 de mayo de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Pantoprazol en el embarazo

Cita de la parte sobre embarazo (Pregnancy) de la etiqueta aprobada por la FDA. Se muestra en inglés. Pregunte a su médico antes de tomar cualquier medicamento si está embarazada o planea estarlo.

Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole.

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Reproduction studies have been performed in rats at oral doses up to 450 mg/kg/day (about 88 times the recommended human dose) and rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study (see Data). A pre-and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. Changes in bone morphology were observed in pups exposed to pantoprazole in utero and through milk during the period of lactation as well as by oral dosing from postnatal day (PND) 4 through PND 21 [see Use in Specific Populations (8.4)]. There were no drug-related findings in maternal animals. Advise pregnant women of the potential risk of fetal harm. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use. Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. In a prospective study by the European Network of Teratology Information Services, outcomes from a group of 53 pregnant women administered median daily doses of 40 mg pantoprazole were compared to a control group of 868 pregnant women who did not take any proton pump inhibitors (PPIs). There was no difference in the rate of major malformations between women exposed to PPIs and the control group, corresponding to a Relative Risk (RR)=0.55, [95% Confidence Interval (CI) 0.08–3.95]. In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to pantoprazole in 549 live births.

— Etiqueta de la FDA: Protonix Delayed-Release, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., vigente desde el 18 de mayo de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Pantoprazol

Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.

• PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6)].

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• Proton pump inhibitors (PPIs), including PROTONIX, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)].
• Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4)
• Patients receiving rilpivirine-containing products (4, 7)

— Etiqueta de la FDA: Protonix Delayed-Release, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., vigente desde el 18 de mayo de 2026. Leer la etiqueta completa en DailyMed →

Sobredosis de Pantoprazol

Cita de la sección «Overdosage» (sobredosis) de la etiqueta aprobada por la FDA. Se muestra en inglés. Si alguien pudo haber tomado demasiado, llame a Poison Help al 1-800-222-1222 (o al 911 en una emergencia).

Experience in patients taking very high doses of PROTONIX (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of PROTONIX. Pantoprazole is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive. Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively.

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The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor. If overexposure to PROTONIX occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

— Etiqueta de la FDA: Protonix Delayed-Release, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., vigente desde el 18 de mayo de 2026. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

Empresas que tienen este medicamento

Empresas en el directorio NDC de la FDA: la empresa que aparece en el envase (fabricante o distribuidor), con su número de productos con receta.

• NuCare Pharmaceuticals, Inc.10 productos
• Cardinal Health 107, LLC10 productos
• Bryant Ranch Prepack7 productos
• Asclemed USA, Inc.6 productos
• A-S Medication Solutions6 productos
• Proficient Rx LP5 productos
• Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.5 productos
• Advanced Rx Pharmacy of Tennessee, LLC4 productos
• Camber Pharmaceuticals, Inc.4 productos
• Hawaii Repack, Inc.4 productos
• Advanced Rx of Tennessee, LLC3 productos
• Major Pharmaceuticals3 productos
• QPharma, Inc.3 productos
• NorthStar RxLLC3 productos
• Northwind Health Company, LLC3 productos
• Aurobindo Pharma Limited3 productos
• Baxter Healthcare Company3 productos
• Remedyrepack Inc.3 productos
• American Health Packaging3 productos
• AvPAK3 productos
• Sun Pharmaceutical Industries, Inc.3 productos
• Coupler LLC3 productos
• Aphena Pharma Solutions - Tennessee, LLC3 productos
• Sportpharm LLC2 productos
• Golden State Medical Supply, Inc.2 productos
• NorthStar Rx LLC2 productos
• Mylan Pharmaceuticals Inc.2 productos
• NCS HealthCare of KY, LLC dba Vangard Labs2 productos
• Chartwell RX, LLC2 productos
• Phoenix RX LLC2 productos
• Torrent Pharmaceuticals Limited2 productos
• Lifestar Pharma LLC2 productos
• Meitheal Pharmaceuticals Inc.2 productos
• PD-Rx Pharmaceuticals, Inc.2 productos
• Hikma Pharmaceuticals USA Inc.2 productos
• Dr. Reddy's Laboratories Limited2 productos
• St. Mary's Medical Park Pharmacy2 productos
• Lannett Company, Inc.2 productos
• Quallent Pharmaceuticals Health LLC2 productos
• Unit Dose Solutions, Inc.2 productos
• Amneal Pharmaceuticals LLC2 productos
• Rising Pharma Holdings, Inc.2 productos
• Granules Pharmaceuticals Inc.2 productos
• Direct_Rx2 productos
• Preferred Pharmaceuticals Inc.2 productos
• XLCare Pharmaceuticals, Inc.2 productos
• Quality Care Products, LLC1 producto
• Sagent Pharmaceuticals1 producto
• Edenbridge Pharmaceuticals LLC.1 producto
• Alembic Pharmaceuticals Inc.1 producto
• Devatis, Inc.1 producto
• Sandoz Inc1 producto
• Novadoz Pharmaceuticals LLC1 producto
• Ajanta Pharma USA Inc.1 producto
• Burel Pharmaceuticals, LLC1 producto
• Safecor Health LLC1 producto
• Eugia US LLC1 producto
• Gland Pharma Limited1 producto
• Fresenius Kabi USA, LLC1 producto
• Cipla USA Inc.1 producto
• Redpharm Drug1 producto
• Mylan Institutional Inc.1 producto
• BE Pharmaceuticals Inc.1 producto
• Civica, Inc.1 producto
• Alembic Pharmaceuticals Limited1 producto
• Avenacy, LLC1 producto
• Piramal Critical Care1 producto

Historial de aprobación de la FDA

• NDA: Solicitud de nuevo medicamento (NDA): así se aprueba un medicamento nuevo, normalmente de marca.
• ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.

Aprobaciones de genéricos (28)

• ANDA077619DR Reddys Labs Ltd · 19 de enero de 2011
• ANDA090074Torrent Pharms · 19 de enero de 2011
• ANDA090970Mylan Pharms Inc · 19 de enero de 2011
• ANDA078281Lannett Co Inc · 20 de enero de 2011
• ANDA202038Aurobindo Pharma Ltd · 28 de septiembre de 2012
• ANDA202882Hetero Labs Ltd V · 10 de septiembre de 2014
• ANDA205119Amneal Pharms · 26 de enero de 2016
• ANDA205675Eugia Pharma · 30 de marzo de 2016
• ANDA077674Sun Pharm · 19 de agosto de 2019
• ANDA213725Sun Pharm · 30 de junio de 2020
• ANDA209524Hangzhou Zhongmei · 30 de agosto de 2021
• ANDA204400Gland · 18 de mayo de 2022
• ANDA213778Aspiro · 18 de mayo de 2022
• ANDA216171Be Pharms · 18 de mayo de 2022
• ANDA214680Knack · 19 de mayo de 2022
• ANDA215880Mankind Pharma · 26 de julio de 2022
• ANDA215860Meitheal · 29 de agosto de 2022
• ANDA217416Ajanta Pharma Ltd · 9 de febrero de 2023
• ANDA216247Dexcel · 16 de junio de 2023
• ANDA216139Annora Pharma · 27 de octubre de 2023
• ANDA217282Granules · 11 de diciembre de 2023
• ANDA216021Fresenius Kabi USA · 1 de agosto de 2024
• ANDA219087Graviti Pharms · 16 de enero de 2025
• ANDA217458Cipla · 31 de marzo de 2025
• ANDA217923Aurobindo Pharma Ltd · 31 de marzo de 2025
• ANDA219230Alembic · 31 de marzo de 2025
• ANDA215074Deva Holding As · 16 de mayo de 2025
• ANDA219973Shuangcheng · 22 de abril de 2026

Escasez

La lista de escasez de la FDA no incluye estos productos.

Base de datos de escasez de medicamentos de la FDA →

Retiros del mercado

De los informes de la FDA, vinculados por el código NDC del producto. Un retiro suele afectar solo a lotes concretos: revise el número de lote del envase y pregunte a su farmacéutico. No deje un medicamento por su cuenta.

1. 6 de agosto de 2026 · Clase II · En curso · D-0812-2026

   CGMP Deviations

   Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-96 — Baxter Healthcare Corporation

2. 26 de marzo de 2026 · Clase II · En curso · D-0484-2026

   Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

   Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, M — Hetero Labs Limited (Unit V)

3. 5 de septiembre de 2023 · Clase II · Cerrado por la FDA · D-1148-2023

   Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

   Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distr — BE PHARMACEUTICALS AG

4. 14 de marzo de 2023 · Clase II · En curso · D-0530-2023

   CGMP Deviations: Discoloration

   Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar — Hetero USA Inc

5. 25 de julio de 2022 · Clase II · Cerrado por la FDA · D-0068-2023

   Discoloration

   Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Onl — SUN PHARMACEUTICAL INDUSTRIES INC

6. 11 de abril de 2022 · Clase II · Cerrado por la FDA · D-0852-2022

   CGMP deviations: tablets cracking

   Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, N — Torrent Pharma Inc

7. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0506-2021

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA — Cardinal Health Inc.

8. 5 de febrero de 2021 · Clase III · Cerrado por la FDA · D-0251-2021

   Failed Impurity/Degradation Specifications

   Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-38 — SUN PHARMACEUTICAL INDUSTRIES INC

9. 4 de diciembre de 2017 · Clase I · Cerrado por la FDA · D-0340-2018

   Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass

   Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00 — AuroMedics Pharma LLC

10. 16 de diciembre de 2016 · Clase III · Cerrado por la FDA · D-0470-2017

    Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

    Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00 — Aurobindo Pharma USA Inc

11. 22 de noviembre de 2016 · Clase III · Cerrado por la FDA · D-0516-2017

    Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.

    PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, — Pfizer Inc.

Identificadores oficiales

Siguientes pasos

• Encuentre una farmacia cerca de ustedPregunte qué precio le corresponde y si su producto está afectado por un retiro
• Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
• Protonix I.V.Página de marca: productos, fabricante y precio
• Protonix Delayed-ReleasePágina de marca: productos, fabricante y precio
• Enfermedad por reflujo gastroesofágico (ERGE)Enfermedad que menciona la etiqueta: hospitales que la tratan
• NuCare Pharmaceuticals, Inc.Fabricante o distribuidor
• Cardinal Health 107, LLCFabricante o distribuidor
• Bryant Ranch PrepackFabricante o distribuidor
• Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español

Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Protonix Delayed-Release, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., vigente desde el 18 de mayo de 2026; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
2. NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
3. Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
4. Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026
5. Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
6. Nombre en español: RxNorm (Biblioteca Nacional de Medicina de EE. UU.) y Wikidata, vinculados por el identificador RxNorm (RxCUI) del principio activo, sin coincidencias aproximadas.

La FDA ofrece los datos de openFDA tal cual; pueden estar incompletos. Guíese siempre por la etiqueta que viene con su medicamento. Buscador de informes de retiros de la FDA →

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