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Recall Observatory FDA recall evidence

Drug 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.

D-1282-2022

June 29, 2022

Class III

Product summary

Firm
Glenmark Pharmaceuticals Inc., USA
Event
Event 90543
Status
Ongoing
Classification
Class III
Quantity
168936 bottles
Official record key
drug-enforcement:D-1282-2022

Official wording

Reason: Failed Tablet/Capsule Specification : Capsule breakage

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.

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specification : Capsule breakage