FDA Recall D-1043-2019

Camber Pharmaceuticals Inc · Piscataway, NJ

Class II Ongoing 2632 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: 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

Quantity: 683,641 bottles

Reason for recall

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

Recall record

Recall number: D-1043-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide
Recall initiated: 2019-02-28
Classified by FDA Center: 2019-03-21
FDA published: 2019-03-27
Recalling firm: Camber Pharmaceuticals Inc
Firm location: Piscataway, NJ

Drug identification

Brand name(s): LOSARTAN POTASSIUM
Generic name(s): LOSARTAN POTASSIUM
Manufacturer(s): Camber Pharmaceuticals, Inc.
NDC(s): 31722-700, 31722-701, 31722-702
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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