FDA Drug recall D-0973-2022
Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SID…
- FDA Drug
- Class II
- terminated
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SID… by Strides Pharma, citing CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0973-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-18 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Strides Pharma |
| Distribution | US |
Product
Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Identifiers
| ndc | 64380-933-04 |
|---|---|
| ndc | 64380-933-05 |
| ndc | 64380-933-08 |
| ndc | 64380-934-04 |
| ndc | 64380-934-05 |
| ndc | 64380-934-08 |
| ndc | 64380-935-04 |
| ndc | 64380-935-05 |
| ndc | 64380-935-08 |
| code_info | NDC 64380-934-05 Lot 7901146A, 7901147A, 7901148A & 7901149A, Exp Date Sep-22; Lot 7901279A, 7901280A, 7901281A, 79012…NDC 64380-934-05 Lot 7901146A, 7901147A, 7901148A & 7901149A, Exp Date Sep-22; Lot 7901279A, 7901280A, 7901281A, 7901282A, 7901283A & 7901284A, Exp Date Nov-22; Lot 7901359A, 7901360A & 7901361A, Exp Date Dec-22; Lot 7901362A, 7901406A, 7901407A, 7901408A & 7901409A, Exp Date Jan-23. 64380-934-08 Lot 7901008A & 7901009A, Exp Date Jun-22; Lot 7901150A & 7901151A, Exp Date Sep-22; Lot 7901285B, 7901286B, 7901287A, 7901288A, 7901289A, 7901290A, 7901291A, 7901292A, 7901293A & 7901294A, Exp Date Nov-22. |
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-0973-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.