D-0659-2020 Class II Terminated
FDA drug recall D-0659-2020 was initiated by Sun Pharmaceutical Industries, Inc. on December 26, 2019 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. The recall status is terminated (terminated October 22, 2020). Affected quantity: 384/100 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2020
- Initiation Date
- December 26, 2019
- Termination Date
- October 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 384/100 count bottles
Product Description
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.
Distribution Pattern
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
Code Information
a) JKU1939A, JKU1940A, JKU1940B, exp. date 04/2022 and b) JKT4175A, exp. date 11/2020