Drug recall D-0659-2020
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
Reason for recall
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Lots and codes
a) JKU1939A, JKU1940A, JKU1940B, exp. date 04/2022 and b) JKT4175A, exp. date 11/2020
Recall details
- Recalling firm
- Sun Pharmaceutical Industries, Inc., Cranbury, NJ
- Quantity
- 384/100 count bottles
- Distribution
- Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 26, 2019
- Terminated
- October 22, 2020
Related products
- Sumatriptan Succinate – drug information
- NDC 62756-521 Sumatriptan succinate · Sumatriptan Succinate 50 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 62756-522 Sumatriptan succinate · Sumatriptan Succinate 100 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 62756-520 Sumatriptan succinate · Sumatriptan Succinate 25 mg/1 · Sun Pharmaceutical Industries, Inc.