Drug product
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
D-0659-2020
Product summary
- Event
- Event 84570
- Status
- Terminated
- Classification
- Class II
- Quantity
- 384/100 count bottles
- Official record key
drug-enforcement:D-0659-2020
Official wording
Reason: Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Code information: a) JKU1939A, JKU1940A, JKU1940B, exp. date 04/2022 and b) JKT4175A, exp. date 11/2020
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