SUMATRIPTAN SUCCINATE Recall D-1111-2022
Description: Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx only, MFG: Sun Pharmaceuticals, NDC 62756-522-69
SUMATRIPTAN SUCCINATE Recall D-1111-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1111-2022 |
| Event ID | 89646 |
| Brand | SUMATRIPTAN SUCCINATE |
| Generic Name | SUMATRIPTAN SUCCINATE |
| Manufacturer | SUMATRIPTAN SUCCINATE |
| Original Package? | 1 |
| Active Substance | SUMATRIPTAN SUCCINATE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 1 carton/9 blister packs |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 62756-520 62756-521 62756-522 |
| Drug UPC | 0362756521889 0362756522886 0362756520882 |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | J8BDZ68989 |
| Drug Application Number | ANDA078295 |
| Structured Product Labeling (SPL ID) | 22ae72f3-2648-46ae-928f-f158ed0bcf27 |
| Structured Product Labeling (SPL Set ID) | 9485cc30-15e8-4b53-876d-db317145474b |
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