PlainRecordsFDA · Drug recall
Sumatriptan Succinate Tablets… and 1 more product
- Date
- Jan. 22, 2020
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Sun Pharmaceutical Industries, Inc.
- Reason
- 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.
2 products in this recall
Sumatriptan Succinate Tablets…
- 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
- Quantity
- 384/100 count bottles
- Codes and lots
- a) JKU1939A, JKU1940A, JKU1940B, exp. date 04/2022 and b) JKT4175A, exp. date 11/2020
- Recall started
- Dec. 26, 2019
- Recall number
- D-0659-2020
Sumatriptan Succinate Tablets…
- Product
- Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
- Quantity
- 207,585 blisters
- Codes and lots
- JKT4174A, exp. date 11/2021 JKU0622A, exp. date 01/2022 JKU1308A, exp. date 02/2022
- Recall started
- Dec. 26, 2019
- Recall number
- D-0660-2020
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-0659-2020, D-0660-2020. The agency record governs; check it and the company before acting.