Recalls / Class II
Class IID-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
- 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) 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
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
- 351,732 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-1041-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.