D-0660-2020 Class II Terminated

Recalled by Sun Pharmaceutical Industries, Inc. — Cranbury, NJ

Recall Details

Product Type
Drugs
Report Date
January 22, 2020
Initiation Date
December 26, 2019
Termination Date
October 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
207,585 blisters

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.

Distribution Pattern

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

Code Information

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