Multi-event December 2019 FDA Recall Sumatriptan Succinate by Sun Pharmaceutical Industries, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on December 26, 2019 for the product Sumatriptan Succinate. The FDA reported the reason for recall as failed impurities/degradation specifications; out-of-specification results obtained for related substance.. The product was distributed in Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0660-2020
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
12-26-2019
01-22-2020
207,585 blisters
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
10-22-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
Batch or Lot Expiration Information
Lot# JKT4174A, exp. date 11/2021 JKU0622A, exp. date 01/2022 JKU1308A, exp. date 02/2022
Recall Number: D-0659-2020
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
12-26-2019
01-22-2020
384/100 count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
10-22-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
