Camber Pharmaceuticals Inc: 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:

Is my product affected?

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

• 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, 100 mg in 30-count, 90-count, and 1000-count bottles due to current Good Manufacturing Practice (CGMP) deviations and trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient. The recall affects 683,641 bottles distributed nationwide, with affected lot numbers and expiration dates ranging from May 2019 through June 2020 specified for each bottle size.

The source document does not specify a remedy or recommended action for consumers who possess affected product.

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: 683,641 bottles Lot/code info: 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

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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