Multi event Drug Recall Enforcement Report Class II voluntary initiated by Sun Pharmaceutical Industries, Inc., originally initiated on 12-26-2019 for the product Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ The product was recalled due to failed impurities/degradation specifications; out-of-specification results obtained for related substance.. The product was distributed in Product Was Distributed Throughout The United States To 96 Distributors And 1 Repacker/relabeler. and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0660-2020 | 12-26-2019 | 01-22-2020 | Class II | 207,585 blisters | Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Terminated |
| D-0659-2020 | 12-26-2019 | 01-22-2020 | Class II | 384/100 count bottles | Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count bottles, (NDC 62756-521-88), Rx only, Sun Pharma, Cranbury, NJ | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Terminated |
Recalled Products
