Recalls / Class III
Class IIID-1282-2022
Product
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.
- Brand name
- Asprin And Extended-release Dipyridamole
- Generic name
- Asprin And Extended-release Dipyridamole
- Active ingredients
- Aspirin, Dipyridamole
- Route
- Oral
- NDC
- 68462-405
- FDA application
- ANDA210318
- Affected lot / code info
- 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.
Why it was recalled
Failed Tablet/Capsule Specification : Capsule breakage
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 168936 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-06-29
- FDA classified
- 2022-07-18
- Posted by FDA
- 2022-07-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1282-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.