LOSARTAN POTASSIUM Recall D-0838-2022
Description: Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
LOSARTAN POTASSIUM Recall D-0838-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0838-2022 |
| Event ID | 89916 |
| Brand | LOSARTAN POTASSIUM |
| Generic Name | LOSARTAN POTASSIUM |
| Manufacturer | LOSARTAN POTASSIUM |
| Original Package? | 1 |
| Active Substance | LOSARTAN POTASSIUM |
| Drug Route | ORAL |
| Distribution | Product was distributed nationwide |
| Quantity | 657,336 bottles |
| Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| Drug Classification | Class II |
| Drug Code Info | 20220511 |
| Product NDC | 68180-376 68180-210 68180-211 |
| Drug UPC | 0368180211068 0368180212065 0368180210061 |
| Recall Initiation Date | 20220331 |
| Report Date | 20220511 |
| Classification Date | 20220503 |
| Address | Harborplace Tower111 S Calvert St Fl 21st Baltimore, MD 21202-6174 United States |
| Recalling Firm | Lupin Pharmaceuticals Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 3ST302B24A |
| Drug Application Number | ANDA078232 |
| Structured Product Labeling (SPL ID) | b20b3678-bd1a-4ca6-9f79-b4a27aa003bd |
| Structured Product Labeling (SPL Set ID) | e5886220-43b7-46e1-9034-5242ba245bd1 |
| Similar To |