Recalls / Class II
Class IID-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
- Brand name
- Sumatriptan Succinate
- Generic name
- Sumatriptan Succinate
- Active ingredient
- Sumatriptan Succinate
- Route
- Oral
- NDCs
- 62756-520, 62756-521, 62756-522
- FDA application
- ANDA078295
- Affected lot / code info
- a) JKU1939A, JKU1940A, JKU1940B, exp. date 04/2022 and b) JKT4175A, exp. date 11/2020
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
- 384/100 count bottles
- 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-0659-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.