Why it was recalled
Failed Tablet/Capsule Specification : Capsule breakage
Product description
Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60.
Lot numbers, UPCs & expiration codes
Lot#: 17201639, Exp 08/2022; 17201759, Exp 09/2022; 17202067, Exp 10/2022; 17210696, Exp 02/2023; 17210092, Exp 11/2022; 17210145, Exp 12/2022; 17210732, Exp 02/2023; 17211062, Exp 04/2023; 17211441, Exp 05/2023; 17211670, Exp 06/2023; 17211810, Exp 07/2023; 17211862, 17212020, 17212068, Exp 08/2023; 17212438, Exp 10/2023; 17220172, 17220251, Exp 12/2023.
Where it was sold
USA Nationwide
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-1282-2022
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 29, 2022
- FDA report date
- Jul 27, 2022
- Quantity
- 168936 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-1282-2022, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 90543
- Address
- 750 Corporate Dr
- Code information
- Lot#: 17201639, Exp 08/2022; 17201759, Exp 09/2022; 17202067, Exp 10/2022; 17210696, Exp 02/2023; 17210092, Exp 11/2022; 17210145, Exp 12/2022; 17210732, Exp 02/2023; 17211062, Exp 04/2023; 17211441, Exp 05/2023; 17211670, Exp 06/2023; 17211810, Exp 07/2023; 17211862, 17212020, 17212068, Exp 08/2023; 17212438, Exp 10/2023; 17220172, 17220251, Exp 12/2023.
- Postal code
- 07430-2009
- Report date
- Jul 27, 2022
- Product type
- Drugs
- Recall number
- D-1282-2022
- Classification
- Class III
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 168936 bottles
- Reason for recall
- Failed Tablet/Capsule Specification : Capsule breakage
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jun 29, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 18, 2022