Drug recall D-1041-2019
Product
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
Reason for recall
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Lots and codes
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
Recall details
- Recalling firm
- Camber Pharmaceuticals Inc, Piscataway, NJ
- Quantity
- 351,732 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 28, 2019
Related products
- Losartan potassium – drug information
- NDC 31722-702 Losartan Potassium · Losartan Potassium 100 mg/1 · Camber Pharmaceuticals, Inc.
- NDC 31722-701 Losartan Potassium · Losartan Potassium 50 mg/1 · Camber Pharmaceuticals, Inc.
- NDC 31722-700 Losartan Potassium · Losartan Potassium 25 mg/1 · Camber Pharmaceuticals, Inc.