Recall: D-0659-2020

Class II - Potentially Harmful

Class IIClassification

2019-12-26Initiated

TerminatedStatus

Sun Pharmaceutical Industries,Firm

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

Reason

Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

Distribution

Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.