Drug recall D-1042-2019
Product
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
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) 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
Recall details
- Recalling firm
- Camber Pharmaceuticals Inc, Piscataway, NJ
- Quantity
- 69712 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.