Drug product
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
D-0660-2020
Product summary
- Event
- Event 84570
- Status
- Terminated
- Classification
- Class II
- Quantity
- 207,585 blisters
- Official record key
drug-enforcement:D-0660-2020
Official wording
Reason: Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Code information: JKT4174A, exp. date 11/2021 JKU0622A, exp. date 01/2022 JKU1308A, exp. date 02/2022
Distribution pattern: Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
Derived failure modes
-
Potency or specification failure
out-of-specification