Pravastatina (pravastatin sodium)

Para qué se usa Pravastatina

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.

Pravastatin sodium tablets are indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). …

— Etiqueta de la FDA: Pravastatin Sodium, Apotex Corp., vigente desde el 31 de julio de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (tablet, oral), Pravastatin Sodium, Apotex Corp.; abarca 4 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 118 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.

0 de 118 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.

Efectos secundarios de Pravastatina

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 important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2)] Hepatic Dysfunction [see Warnings and Precautions (5.3)] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4)] In short-term clinical trials, the most commonly reported adverse reactions (≥2% and greater than placebo) were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache.

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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Apotex at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In pravastatin placebo-controlled clinical trials, 1,313 patients (age range 20 to 76 years, 32% women, 93.5% White, 5% Black, 0.9% Hispanic, 0.4% Asian, 0.2% Other) with a median treatment duration of 14 weeks, 3.3% of patients on pravastatin and 1.2% patients on placebo discontinued due to adverse reactions (regardless of causality). The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: hepatic transaminase elevations, nausea, anxiety/depression, and dizziness. Adverse reactions (regardless of causality) reported in ≥2% of pravastatin-treated patients in placebo-controlled trials of up to 8 months duration are identified in Table 1: Table 1: Adverse Reactions in ≥ 2% of Patients Treated with Pravastatin (Any Dose) and at an Incidence Greater Than Placebo in Short-Term Placebo-Controlled Trials % Placebo N=411 % Any Dose N=902 Nausea/Vomiting 7.1 7.4 Diarrhea 5.6 6.7 Headache 4.6 6.3 Upper Respiratory Infection 5.8 5.9 Angina Pectoris 3.4 4.5 Rash 1.4 4.5 CPK Increased 3.6 4.1 Dizziness 3.4 3.5 ALT Increased 1.2 2.9 Chest Pain 1.9 2.7 Cough 1.7 2.5 Myalgia 1.2 2.3 Influenza 0.7 2.0 g-GT Increased 1.2 2.0 Adverse Reactions (regardless of causality) The safety and tolerability of pravastatin at a dose of 80 mg in 2 controlled trials with a mean exposure of 8.6 months was similar to that of pravastatin at lower doses except that 4 out of 464 patients taking 80 mg of pravastatin had a single elevation of CK >10 times ULN compared to 0 out of 115 patients taking 40 mg of pravastatin. In pravastatin placebo-controlled clinical trials, 21,483 patients (age range 24 to 75 years, 10.3% women, 52.3% White, 0.8% Black, 0.5% Hispanic, 0.1% Asian, 0.1% Other, 46.1% not recorded) had a median treatment duration of 261 weeks.

— Etiqueta de la FDA: Pravastatin Sodium, Apotex Corp., vigente desde el 31 de julio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Pravastatina

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.

See full prescribing information for details regarding concomitant use of pravastatin sodium tablets with other drugs that increase the risk of myopathy and rhabdomyolysis.

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(2.5, 7.1) Bile Acid Sequestrants: in patients taking a bile acid sequestrant, administer pravastatin sodium tablets at least 1 hour before or at least 4 hours after the bile acid sequestrant (7.2) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Pravastatin Pravastatin is a substrate of the transport protein OATP1B1. Pravastatin plasma levels can be significantly increased with concomitant administration of inhibitors of OATP1B1. Table 3 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with pravastatin and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)]. Table 3: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Pravastatin Gemfibrozil Clinical Impact: There is an increased risk of myopathy/rhabdomyolysis when pravastatin is administered with gemfibrozil Intervention: Avoid concomitant use of gemfibrozil with pravastatin. Cyclosporine Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine with pravastatin. Intervention: Initiate with a dosage of pravastatin sodium 10 mg once daily. Do not exceed pravastatin 20 mg once daily [see Dosage and Administration (2.5)]. Select Macrolide Antibiotics Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of clarithromycin or erythromycin with pravastatin. Other macrolides (e.g., azithromycin) have the potential to increase pravastatin exposures and increase the risk of myopathy and rhabdomyolysis when used concomintantly. Intervention: For patients taking erythromycin or clarithromycin, do not exceed 40 mg pravastatin once daily [see Dosage and Administration (2.5)]. Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of niacin with pravastatin. Intervention: Consider if the benefit of using niacin concomitantly with pravastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Fibrates (other than Gemfibrozil) Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with pravastatin. Intervention: Consider if the benefit of using fibrates concomitantly with pravastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug.

— Etiqueta de la FDA: Pravastatin Sodium, Apotex Corp., vigente desde el 31 de julio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Pravastatina

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.

Take orally once daily at any time of the day, with or without food (2.1). For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving pravastatin sodium tablets 80 mg daily, prescribe alternative LDL-C-lowering treatment (2.1). Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating pravastatin sodium tablets, and adjust the dosage if necessary (2.1).

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Adults: recommended starting dosage is pravastatin sodium tablets 40 mg to 80 mg once daily. (2.2) Pediatric Patients (2.3): aged 8 to 13 years, the recommended dosage is 20 mg once daily. aged 14 to 18 years, the recommended starting dosage is 40 mg once daily. Severe renal impairment: recommended starting dosage is pravastatin sodium 10 mg once daily. Use another pravastatin sodium product to initiate dosing. Recommended maximum pravastatin sodium tablets dosage is 40 mg once daily. (2.4) See full prescribing information for dosage modifications due to drug interactions (2.5, 7). 2.1 Important Dosage and Administration Information Take pravastatin sodium tablets orally once daily as a single dose at any time of the day, with or without food. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving pravastatin sodium tablets 80 mg daily, prescribe alternative LDL-C-lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating pravastatin sodium tablets, and adjust the dosage if necessary. 2.2 Recommended Dosage in Adult Patients The recommended starting dosage is pravastatin sodium tablets 40 mg to 80 mg once daily. 2.3 Recommended Dosage in Pediatric Patients 8 Years of Age and Older with HeFH In pediatric patients aged 8 to 13 years, the recommended dosage is pravastatin sodium tablets 20 mg once daily. In pediatric patients aged 14 to 18 years, the recommended starting dosage is pravastatin sodium tablets 40 mg once daily. 2.4 Recommended Dosage in Patients with Renal Impairment In patients with severe renal impairment, the recommended starting dosage is pravastatin sodium 10 mg once daily. The maximum recommended dosage of pravastatin sodium tablets in patients with severe renal impairment is 40 mg once daily [see Clinical Pharmacology (12.3)]. The recommended dosage of pravastatin sodium tablets for patients with mild or moderate renal impairment is the same as patients with normal renal function. 2.5 Dosage and Administration Modifications Due to Drug Interactions In patients taking a bile acid sequestrant, administer pravastatin sodium tablets at least 1 hour before or 4 hours after the bile acid sequestrant [see Drug Interactions (7.2)]. Concomitant use of pravastatin sodium tablets with the following drugs requires dosage modifications of pravastatin sodium tablet s [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]: Cyclosporine In patients taking cyclosporine, the recommended starting dosage is pravastatin sodium 10 mg once daily. The maximum recommended dosage of pravastatin sodium tablets in patients taking cyclosporine is 20 mg once daily.

— Etiqueta de la FDA: Pravastatin Sodium, Apotex Corp., vigente desde el 31 de julio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Pravastatina 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 Discontinue pravastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Pravastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pravastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)].

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In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. Published data from prospective and retrospective observational cohort studies with pravastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data). In animal reproduction studies, no evidence of fetal malformations was seen in pregnant rats or rabbits orally administered pravastatin during the period of organogenesis at doses that resulted in 10 times and 120 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg/day, based on body surface area (mg/m 2). An imbalance in some fetal skeletal variations, increased offspring mortality, and developmental delays occurred when pregnant rats were exposed to 10 times to 12 times the MRHD during organogenesis to parturition (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential cofounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for cofounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified.

— Etiqueta de la FDA: Pravastatin Sodium, Apotex Corp., vigente desde el 31 de julio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Pravastatina y la lactancia

Cita de la parte sobre lactancia (Nursing Mothers) de la etiqueta aprobada por la FDA. Se muestra en inglés.

Risk Summary Based on one lactation study in published literature, pravastatin is present in human milk. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Statins, including pravastatin, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant.

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Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with pravastatin [see Use in Specific Populations (8.1), Clinical Pharmacology (12.1)].

— Etiqueta de la FDA: Pravastatin Sodium, Apotex Corp., vigente desde el 31 de julio de 2026. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Pravastatina

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

Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)]. Hypersensitivity to any pravastatin or any excipients in pravastatin sodium tablets. Hypersensitivity to pravastatin or any excipient in pravastatin sodium tablets (4) Acute liver failure or decompensated cirrhosis (4, 5.3)

— Etiqueta de la FDA: Pravastatin Sodium, Apotex Corp., vigente desde el 31 de julio de 2026. Leer la etiqueta completa en DailyMed →

Sobredosis de Pravastatina

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).

No specific antidotes for pravastatin are known. Contact Poison Control (1-800-222-1222) for latest recommendations.

— Etiqueta de la FDA: Pravastatin Sodium, Apotex Corp., vigente desde el 31 de julio 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.

• Bryant Ranch Prepack31 productos
• A-S Medication Solutions25 productos
• Aurobindo Pharma Limited9 productos
• NCS HealthCare of KY, LLC dba Vangard Labs8 productos
• Preferred Pharmaceuticals Inc.8 productos
• Northwind Health Company, LLC7 productos
• NuCare Pharmaceuticals, Inc.6 productos
• Direct_Rx5 productos
• Remedyrepack Inc.5 productos
• PD-Rx Pharmaceuticals, Inc.4 productos
• Golden State Medical Supply, Inc.4 productos
• Chartwell RX, LLC4 productos
• Lupin Pharmaceuticals, Inc.4 productos
• Cipla USA Inc.4 productos
• NorthStar RxLLC4 productos
• Accord Healthcare Inc.4 productos
• Amici Pharma, Inc.4 productos
• Biocon Pharma Inc.4 productos
• Proficient Rx LP4 productos
• AvPAK4 productos
• Dr. Reddy's Laboratories Limited4 productos
• Apotex Corp.4 productos
• Aphena Pharma Solutions - Tennessee, LLC4 productos
• Glenmark Pharmaceuticals Inc., USA4 productos
• Major Pharmaceuticals3 productos
• American Health Packaging3 productos
• Coupler LLC3 productos
• Quallent3 productos
• Cardinal Health 107, LLC3 productos
• Safecor Health LLC2 productos
• Teva Pharmaceuticals, Inc.1 producto
• Quality Care Products, LLC1 producto
• Teva Pharmaceuticals USA, Inc.1 producto
• Lake Erie Medical DBA Quality Care Products LLC1 producto

Historial de aprobación de la FDA

• ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.

Aprobaciones de genéricos (10)

• ANDA076056Aurobindo Pharma USA · 24 de abril de 2006
• ANDA076341Apotex · 23 de octubre de 2006
• ANDA076714DR Reddys Labs Inc · 23 de octubre de 2006
• ANDA077987Glenmark Pharms Ltd · 11 de mayo de 2007
• ANDA077917Chartwell Rx · 8 de enero de 2008
• ANDA077793Aurobindo Pharma USA · 15 de enero de 2008
• ANDA077491Pharmazone · 11 de febrero de 2008
• ANDA207068Accord Hlthcare · 17 de noviembre de 2016
• ANDA203367Aurobindo Pharma · 2 de febrero de 2017
• ANDA209869Biocon Pharma · 13 de abril de 2018

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. 13 de marzo de 2025 · Clase II · En curso · D-0325-2025

   CGMP Deviations

   Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 — Glenmark Pharmaceuticals Inc., USA

2. 13 de marzo de 2025 · Clase II · En curso · D-0341-2025

   CGMP Deviations

   Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man — Glenmark Pharmaceuticals Inc., USA

3. 13 de marzo de 2025 · Clase II · En curso · D-0350-2025

   CGMP Deviations

   Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampu — Glenmark Pharmaceuticals Inc., USA

4. 13 de marzo de 2025 · Clase II · En curso · D-0349-2025

   CGMP Deviations

   Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01 — Glenmark Pharmaceuticals Inc., USA

5. 28 de junio de 2024 · Clase II · En curso · D-0612-2024

   Failed Dissolution Specifications: results below specifications

   Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, — Glenmark Pharmaceuticals Inc., USA

6. 7 de febrero de 2023 · Clase II · Cerrado por la FDA · D-0424-2023

   CGMP Deviations: recalling drug products following an FDA inspection.

   Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-0 — Accord Healthcare, Inc.

7. 7 de febrero de 2023 · Clase II · Cerrado por la FDA · D-0421-2023

   CGMP Deviations: recalling drug products following an FDA inspection.

   Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 7; Manufactured for: Accord Healthcare, Inc., — Accord Healthcare, Inc.

8. 7 de febrero de 2023 · Clase II · Cerrado por la FDA · D-0423-2023

   CGMP Deviations: recalling drug products following an FDA inspection.

   Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729- — Accord Healthcare, Inc.

9. 7 de febrero de 2023 · Clase II · Cerrado por la FDA · D-0422-2023

   CGMP Deviations: recalling drug products following an FDA inspection.

   Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-009 — Accord Healthcare, Inc.

10. 25 de marzo de 2019 · Clase II · Cerrado por la FDA · D-1120-2019

    Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.

    Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for — Glenmark Pharmaceuticals Inc., USA

11. 17 de noviembre de 2017 · Clase II · Cerrado por la FDA · D-0092-2018

    Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.

    Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09 — Lupin Limited

12. 11 de julio de 2017 · Clase III · Cerrado por la FDA · D-1038-2017

    Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.

    Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 IND — Dr. Reddy's Laboratories, Inc.

13. 5 de abril de 2013 · Clase III · Cerrado por la FDA · D-330-2013

    Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.

    Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430 — Glenmark Generics Inc., USA

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
• Enfermedad de las arterias coronariasEnfermedad que menciona la etiqueta: hospitales que la tratan
• Accidente cerebrovascularEnfermedad que menciona la etiqueta: hospitales que la tratan
• Bryant Ranch PrepackFabricante o distribuidor
• A-S Medication SolutionsFabricante o distribuidor
• Aurobindo Pharma LimitedFabricante 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) — Pravastatin Sodium, Apotex Corp., vigente desde el 31 de julio 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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