Sun Pharmaceutical Industries, Inc. recalls Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharm…
- Recall date
- December 26, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0660-2020
- FDA classification
- Class II
- Brand / firm
- Sun Pharmaceutical Industries, Inc.
- Sold / distributed
- Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
Why it was recalled
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
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