Losartan Potassium Tablet, Film Coated
FDA Recall NDC 31722-702
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Losartan Potassium (NDC 31722-702). A significant event, classified as Class II, was initiated on Feb 28, 2019 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
February 2019 Class II Recall: CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Recall Number
Class II Ongoing
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Feb 28, 2019
Mar 27, 2019
683,641 bottles
Recall Profile & Regulatory Data
Event ID
82281
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Camber Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
Batch or Lot Expiration Information
Lot# a) LOP17011, Exp Aug-19, Lot LOP17087 Exp Nov-19; b) LOP17012, LOP17013, Exp Aug-19, LOP17042, LOP17043 Exp Oct-19, LOP17044, LOP17045, Exp Nov-19, LOP18024, LOP18025, LOP18026, LOP18027, LOP18028, LOP18029, LOP18030, Exp. Dec-19; c) LOP17005, Exp May-19, LOP17014, Exp Aug-19, LOP17016, LOP17023, Exp Sep-19, LOP17083, Exp Oct-19, LOP17084, LOP17085, LOP17086, Exp Nov-19, LOP18021, LOP18022, LOP18023, LOP18031, LOP18032, LOP18033, LOP18050, LOP18051, Exp Dec-19, LOP18109, LOP18111, Exp Mar-20, LOP18122, LOP18123, LOP18124, LOP18125, LOP18126, LOP18127, LOP18128, LOP18129, LOP18130, LOP18131C, LOP18133, Exp Jun-20
Affected Packages Involved in this Recall
31722-700-30Product
31722-700-60Product
31722-700-90Product
31722-700-05Product
31722-700-10Product
31722-701-30Product
31722-701-60Product
31722-701-90Product
31722-701-05Product
31722-701-10Product
31722-702-30Product
31722-702-60Product
31722-702-90Product
31722-702-05Product
31722-702-10Product
February 2019 Class II Recall: CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Recall Number
Class II Ongoing
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Feb 28, 2019
Mar 27, 2019
69712 bottles
Recall Profile & Regulatory Data
Event ID
82281
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Camber Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
Batch or Lot Expiration Information
Lot# a) LOP17028C, Exp. Sep-19, LOP17064A, Exp. Nov-19; b) LOP17027, Exp Sep-19, LOP17063, LOP17093, Exp. Nov-19; LOP17094, LOP17095, LOP17097A, LOP17105, LOP17107, Exp. Dec-19; c) LOP17004, Exp Dec-19, LOP17028B, Exp Sep-19, LOP17048, LOP17049 Exp Oct-19, LOP17056, LOP17073, LOP17074, LOP17076 Exp Nov-19, LOP17096, Exp Dec-19, LOP18077A, LOP18078, LOP18079, LOP18080 Exp Feb-20; LOP18081, LOP18084, LOP18095, LOP18096 Exp Mar-20
Affected Packages Involved in this Recall
31722-700-30Product
31722-700-60Product
31722-700-90Product
31722-700-05Product
31722-700-10Product
31722-701-30Product
31722-701-60Product
31722-701-90Product
31722-701-05Product
31722-701-10Product
31722-702-30Product
31722-702-60Product
31722-702-90Product
31722-702-05Product
31722-702-10Product
February 2019 Class II Recall: CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Recall Number
Class II Ongoing
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Feb 28, 2019
Mar 27, 2019
351,732 bottles
Recall Profile & Regulatory Data
Event ID
82281
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Camber Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
Batch or Lot Expiration Information
Lot# a) LOP17026B, LOP17050, LOP1705, LOP17052, LOP17053, Exp. Sep-19; LOP17061, Exp. Oct-19; LOP18035, LOP18036, Exp. Dec-19; b) LOP17026, Exp. Sep-19; c) LOP17006, Exp. May-19, LOP17025, Exp. Sep-19, LOP17068, Exp, Oct-19, LOP18037, LOP18038, LOP18039, Exp. Dec-19, LOP18057, Exp. Jan-20
Affected Packages Involved in this Recall
31722-700-30Product
31722-700-60Product
31722-700-90Product
31722-700-05Product
31722-700-10Product
31722-701-30Product
31722-701-60Product
31722-701-90Product
31722-701-05Product
31722-701-10Product
31722-702-30Product
31722-702-60Product
31722-702-90Product
31722-702-05Product
31722-702-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
