Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
Reported: January 22, 2020 Initiated: December 26, 2019 #D-0660-2020
Product Description
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), 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
- 207,585 blisters
- 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, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 207,585 blisters.
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-0660-2020.
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