Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-...
FDA Recall #D-0659-2020 — Class II — December 26, 2019
Product Description
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 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
384/100 count bottles
Distribution
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
Code Information
a) JKU1939A, JKU1940A, JKU1940B, exp. date 04/2022 and b) JKT4175A, exp. date 11/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated