D-1282-2022 Class III Ongoing
FDA drug recall D-1282-2022 was initiated by Glenmark Pharmaceuticals Inc., USA on Jun 29, 2022 and is designated Class III. Reason for recall: Failed Tablet/Capsule Specification : Capsule breakage The recall status is ongoing. Affected quantity: 168936 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 27, 2022
- Initiation Date
- Jun 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 168936 bottles
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.
Reason for Recall
Failed Tablet/Capsule Specification : Capsule breakage
Distribution Pattern
USA Nationwide
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1282-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026