Why it was recalled
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
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
Lot numbers, UPCs & expiration codes
a) JKU1939A, JKU1940A, JKU1940B, exp. date 04/2022 and b) JKT4175A, exp. date 11/2020
Where it was sold
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0659-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 26, 2019
- FDA report date
- Jan 22, 2020
- Quantity
- 384/100 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0659-2020, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84570
- Address
- 270 Prospect Plains Rd
- Code information
- a) JKU1939A, JKU1940A, JKU1940B, exp. date 04/2022 and b) JKT4175A, exp. date 11/2020
- Postal code
- 08512-3605
- Report date
- Jan 22, 2020
- Product type
- Drugs
- Recall number
- D-0659-2020
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 384/100 count bottles
- Termination date
- Oct 22, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
- Recall initiation date
- Dec 26, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2020