Drug recall D-0660-2020

Class II Terminated reported Jan 22, 2020

Product

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.

Lots and codes

JKT4174A, exp. date 11/2021 JKU0622A, exp. date 01/2022 JKU1308A, exp. date 02/2022

Recall details

Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Quantity
207,585 blisters
Distribution
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
Type
Voluntary: Firm initiated
Recall initiated
December 26, 2019
Terminated
October 22, 2020