LOSARTAN POTASSIUM Recall D-0974-2022
Description: Losartan Potassium Tablets, USP, 100 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 64380-935-05 1000 film coated tablets NDC 64380-935-08
LOSARTAN POTASSIUM Recall D-0974-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0974-2022 |
| Event ID | 90229 |
| Brand | LOSARTAN POTASSIUM |
| Generic Name | LOSARTAN POTASSIUM |
| Manufacturer | LOSARTAN POTASSIUM |
| Original Package? | 1 |
| Active Substance | LOSARTAN POTASSIUM |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 96966 bottles |
| Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| Drug Classification | Class II |
| Drug Code Info | 20220608 |
| Product NDC | 64380-933 64380-934 64380-935 |
| Drug UPC | 0364380935056 0364380933083 0364380935087 |
| Recall Initiation Date | 20220516 |
| Report Date | 20220608 |
| Classification Date | 20220528 |
| Address | 2 Tower Center Blvd Ste 1102 East Brunswick, NJ 08816-1100 United States |
| Recalling Firm | Strides Pharma Inc. |
| Unique Ingredient Identifier | 3ST302B24A |
| Drug Application Number | ANDA090382 |
| Structured Product Labeling (SPL ID) | 9bbc4a81-d023-4e75-a771-52af48b21cac |
| Structured Product Labeling (SPL Set ID) | a8817f22-8478-49b9-8354-ab27ca222c6b |
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