Recalls / Class II
Class IID-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
- Brand name
- Losartan Potassium
- Generic name
- Losartan Potassium
- Active ingredient
- Losartan Potassium
- Route
- Oral
- NDCs
- 31722-700, 31722-701, 31722-702
- FDA application
- ANDA203835
- Affected 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
Why it was recalled
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Recalling firm
- Firm
- Camber Pharmaceuticals Inc
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1031 Centennial Ave, N/A, Piscataway, New Jersey 08854-4125
Distribution
- Quantity
- 69712 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-02-28
- FDA classified
- 2019-03-21
- Posted by FDA
- 2019-03-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1042-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.