FDA Recall D-1282-2022

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class III Ongoing 1415 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

Lot / code: 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.

Quantity: 168936 bottles

Reason for recall

Failed Tablet/Capsule Specification : Capsule breakage

Recall record

Recall number: D-1282-2022
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2022-06-29
Classified by FDA Center: 2022-07-18
FDA published: 2022-07-27
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE
Generic name(s): ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-405
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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