¿Emergencia médica?¿Emergencia? Llame al 911. Salas de emergencias más cercanasEmergencias cercanas

English Cerca de mí Mi lista Ayuda
US Patient GuideEE. UU.
Sorpréndeme
Empresa farmacéutica (etiquetadora ante la FDA)

Camber Pharmaceutical Inc

Código de etiquetadora NDC: 31722

¿Qué es una etiquetadora?

La empresa cuyo nombre aparece en el envase y en el directorio de códigos nacionales de medicamentos (NDC) de la FDA. Puede fabricar el medicamento o vender uno fabricado por otra empresa. La primera parte de cada código NDC identifica a la etiquetadora.

Solo datos oficiales de la FDA

Los productos, aprobaciones y retiros vienen de la FDA (directorio NDC, Drugs@FDA, informes de retiros). Los retiros se vinculan a esta empresa por el código NDC del producto retirado.

Si tiene preguntas sobre su medicamento, hable con su médico o farmacéutico. En una emergencia, llame al 911.

De un vistazo

1Medicamentos con receta
3Productos (NDC)
1Solicitudes de la FDA
29Retiros

Medicamentos con receta

Solicitudes de la FDA de estos productos

  • ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.
AprobadaSolicitudMedicamentoPatrocinador
22 de septiembre de 2015ANDA207416 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE		Ascent Pharms Inc

El patrocinador es la empresa titular de la solicitud ante la FDA; puede ser distinta de la etiquetadora.

Cronología de retiros

2026

  1. 4 de junio de 2026 · Clase II · En curso · D-0626-2026 · Lacosamide

    Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.

    Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.

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

    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

2025

  1. 1 de octubre de 2025 · Clase II · En curso · D-0036-2026 · Ketorolac tromethamine

    Presence of Particulate Matter: Particulate matter identified as glass

    Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Tela

2023

  1. 14 de marzo de 2023 · Clase II · En curso · D-0530-2023 · Pantoprazole sodium

    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

  2. 13 de marzo de 2023 · Clase I · En curso · D-0567-2023 · Atovaquone

    Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

    Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India,

2022

  1. 6 de diciembre de 2022 · Clase III · Cerrado por la FDA · D-0094-2023 · Lacosamide

    Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content

    Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055,

2021

  1. 19 de noviembre de 2021 · Clase II · Cerrado por la FDA · D-0276-2022 · Hydrocodone bitartrate and acetaminophen

    Product Mix-up

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central I

2019

  1. 28 de febrero de 2019 · Clase II · En curso · D-1043-2019 · Losartan potassium

    CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

    Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 088

  2. 28 de febrero de 2019 · Clase II · En curso · D-1042-2019 · Losartan potassium

    CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

    Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 0885

  3. 28 de febrero de 2019 · Clase II · En curso · D-1041-2019 · Losartan potassium

    CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

    Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ

Mostrar los 19 retiros anteriores

2018

  1. 12 de septiembre de 2018 · Clase III · Cerrado por la FDA · D-1211-2018 · Fenofibrate

    Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.

    Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90

  2. 20 de agosto de 2018 · Clase II · Cerrado por la FDA · D-1213-2018 · Montelukast

    Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.

    Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, N

  3. 15 de agosto de 2018 · Clase I · En curso · D-0081-2019 · Montelukast

    Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

    Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 088

  4. 8 de agosto de 2018 · Clase II · Completado · D-1113-2018 · Valsartan

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar

  5. 8 de agosto de 2018 · Clase II · Completado · D-1114-2018 · Valsartan

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob

  6. 8 de agosto de 2018 · Clase II · Completado · D-1116-2018 · Valsartan

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nag

  7. 8 de agosto de 2018 · Clase II · Completado · D-1115-2018 · Valsartan

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar

  8. 18 de julio de 2018 · Clase II · Cerrado por la FDA · D-1019-2018 · Indomethacin

    Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.

    Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-

  9. 13 de febrero de 2018 · Clase II · Cerrado por la FDA · D-0601-2018 · Valganciclovir

    Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

    Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India.

  10. 13 de febrero de 2018 · Clase II · Cerrado por la FDA · D-0602-2018 · Valacyclovir

    Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

    Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India NDC #

  11. 22 de enero de 2018 · Clase III · Cerrado por la FDA · D-0248-2018 · Oxycodone hydrochloride

    Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol

    Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01

  12. 10 de enero de 2018 · Clase II · Cerrado por la FDA · D-0594-2018 · Aripiprazole

    CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

    Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India,

2017

  1. 22 de diciembre de 2017 · Clase II · Cerrado por la FDA · D-0415-2018 · Famciclovir

    Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.

    Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. ND

  2. 22 de diciembre de 2017 · Clase III · Cerrado por la FDA · D-0223-2018 · Simvastatin

    Presence of foreign substance: metallic razor blade was found in one bottle.

    Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055

  3. 12 de octubre de 2017 · Clase II · Cerrado por la FDA · D-0099-2018 · Levetiracetam

    Presence of foreign substance (screw)

    Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad -

  4. 20 de julio de 2017 · Clase II · Cerrado por la FDA · D-1095-2017 · Entecavir

    Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.

    Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. N

  5. 27 de abril de 2017 · Clase III · Cerrado por la FDA · D-0897-2017 · Acyclovir

    Presence of Foreign Substance: human hair melded into tablet.

    Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC

  6. 7 de enero de 2017 · Clase III · Cerrado por la FDA · D-0623-2017 · Montelukast

    Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.

    Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, N

2016

  1. 29 de diciembre de 2016 · Clase III · Cerrado por la FDA · D-0453-2017 · Finasteride

    Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.

    Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited

¿Qué significan las clases de retiro?

Clase I: El tipo más grave: existe una probabilidad razonable de que usar el producto cause problemas de salud graves o la muerte.
Clase II: Usar el producto puede causar problemas de salud temporales o reversibles con tratamiento, o la probabilidad de problemas graves es remota.
Clase III: No es probable que usar el producto cause problemas de salud (por ejemplo, un problema de etiquetado o de envase).

Fuentes

  1. 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
  2. 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
  3. 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

Buscador de informes de retiros de la FDA → · Informar un error →