Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-...
FDA Recall #D-0660-2020 — Class II — December 26, 2019
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.
Recalling Firm
Sun Pharmaceutical Industries, Inc. — Cranbury, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
207,585 blisters
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated