Sumatriptan Succinate Tablet, Film Coated
FDA Recall NDC 62756-521
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sumatriptan Succinate (NDC 62756-521). A significant event, classified as Class II, was initiated on Apr 13, 2022 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "cGMP deviations: Temperature abuse"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
1 carton/9 blister packs
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx only, MFG: Sun Pharmaceuticals, NDC 62756-522-69
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
62756-520-83Product
62756-520-88Product
62756-520-08Product
62756-520-18Product
62756-520-69Product
62756-520-93Product
62756-520-01Product
62756-521-83Product
62756-521-88Product
62756-521-08Product
62756-521-18Product
62756-521-69Product
62756-521-93Product
62756-521-01Product
62756-522-83Product
62756-522-88Product
62756-522-08Product
62756-522-18Product
62756-522-69Product
62756-522-93Product
62756-522-01Product
December 2019 Class II Recall: Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Dec 26, 2019
Jan 22, 2020
384/100 count bottles
Recall Profile & Regulatory Data
Event ID
84570
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
Termination Date
Oct 22, 2020
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
Batch or Lot Expiration Information
Lot# a) JKU1939A, JKU1940A, JKU1940B, exp. date 04/2022 and b) JKT4175A, exp. date 11/2020
Affected Packages Involved in this Recall
62756-520-83Product
62756-520-88Product
62756-520-08Product
62756-520-18Product
62756-520-69Product
62756-520-93Product
62756-520-01Product
62756-521-83Product
62756-521-88Product
62756-521-08Product
62756-521-18Product
62756-521-69Product
62756-521-93Product
62756-521-01Product
62756-522-83Product
62756-522-88Product
62756-522-08Product
62756-522-18Product
62756-522-69Product
62756-522-93Product
62756-522-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
