Recalls / Class II
Class IID-1103-2020
Product
Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09
- Affected lot / code info
- a) CL018008A, exp Mar 2020; b) CL018008B, exp Mar 2020; c) CL018009A, exp Mar 2020
Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Recalling firm
- Firm
- Avet Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 1700, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- a) 2,904; b) 14,316; c) 1,368 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-03-26
- FDA classified
- 2020-04-07
- Posted by FDA
- 2020-04-15
- Terminated
- 2021-03-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1103-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.