Camber Pharmaceuticals Inc: 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:

Is my product affected?

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 -

• Brand LOSARTAN POTASSIUM

Check against the official notice below — it lists the full affected range.

What happened

Camber Pharmaceuticals Inc is recalling Losartan Potassium Tablets USP, 50 mg, distributed nationwide in 30-count, 90-count, and 1000-count bottles. The recall affects 69,712 bottles due to current Good Manufacturing Practice (CGMP) deviations and the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) in the active pharmaceutical ingredient. Multiple lot numbers are affected with expiration dates ranging from September 2019 through March 2020.

The affected lot numbers include LOP17028C, LOP17064A, LOP17027, LOP17063, LOP17093, LOP17094, LOP17095, LOP17097A, LOP17105, LOP17107, LOP17004, LOP17028B, LOP17048, LOP17049, LOP17056, LOP17073, LOP17074, LOP17076, LOP17096, LOP18077A, LOP18078, LOP18079, LOP18080, LOP18081, LOP18084, LOP18095, and LOP18096. The source document does not specify a remedy or recommended consumer action.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient Distribution: Nationwide Quantity: 69712 bottles Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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• Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.2022-03-31

All FDA (Drug enforcement) recalls