Recalls / Class II
Class IID-0660-2020
Product
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
- Affected lot / code info
- JKT4174A, exp. date 11/2021 JKU0622A, exp. date 01/2022 JKU1308A, exp. date 02/2022
Why it was recalled
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 207,585 blisters
- Distribution pattern
- Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
Timeline
- Recall initiated
- 2019-12-26
- FDA classified
- 2020-01-13
- Posted by FDA
- 2020-01-22
- Terminated
- 2020-10-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0660-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.