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
Reported: January 22, 2020 Initiated: December 26, 2019 #D-0659-2020
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.
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 384/100 count bottles
- Distribution
- Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 384/100 count bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2020. Severity: Moderate. Recall number: D-0659-2020.
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