FDA Drug recall D-1104-2020
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-…
- FDA Drug
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of 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-… by Avet Pharmaceuticals, citing CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1104-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-26 |
| Published | 2020-04-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avet Pharmaceuticals |
| Distribution | US |
Product
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
Reason
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Identifiers
| code_info | a) CL018022B, exp Apr 2020 b) CL018010A Mar 2020; CL018017B, CL018018A exp Apr 2020 c) CL018011A, CL018012A exp M…a) 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1104-2020%22
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