Class II · ModerateRecall completed
Losartan Potassium Tablets USP 100 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera) CL018022B, exp Apr 2020 b) CL018010A Mar 2020; CL018017B, CL018018A exp Apr 2020 c) CL018011A, CL018012A exp Mar 2020; CL018013A, CL018015A, CL018016A, CL018017A, exp Apr 2020
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byVivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 foreign manufacturer
| Distributed by / for | Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 |
| NDC | 23155-646-03 |
Show the full FDA record
| Full product label | Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 |
| Recalling firm | Avet Pharmaceuticals, Inc. |
| Distribution | Nationwide |
| Quantity | a) 12,168; b) 17,196; c) 3,890 |
| Recall initiated | 2020-03-26 |
| Report date | 2020-04-15 |
| Recall completed | 2021-03-08 |
| Recall number | D-1104-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | East Brunswick NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.