Sumatriptan Succinate Tablets recall: Impurity Out of Spec
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
Why was Sumatriptan Succinate Tablets recalled?
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
JKT4174A, exp. date 11/2021 JKU0622A, exp. date 01/2022 JKU1308A, exp. date 02/2022
- Product
- Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Quantity
- 207,585 blisters
- Distribution
- Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
- Recall date
- January 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)