ASPIRIN Recall D-1282-2022
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.
ASPIRIN Recall D-1282-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1282-2022 |
Event ID | 90543 |
Brand | ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE |
Generic Name | ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE |
Manufacturer | ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE |
Original Package? | 1 |
Active Substance | ASPIRIN DIPYRIDAMOLE |
Drug Route | ORAL |
Distribution | USA Nationwide |
Quantity | 168936 bottles |
Recall Reason | Failed Tablet/Capsule Specification : Capsule breakage |
Drug Classification | Class III |
Drug Code Info | 20220727 |
Product NDC | 68462-405 |
Product NUI | N0000000160 N0000008836 M0001335 |
Pharma Class (PE) | Decreased Prostaglandin Production [PE] |
Pharma Class (EPC) | Nonsteroidal Anti-inflammatory Drug [EPC] |
Pharma Class (CS) | Anti-Inflammatory Agents, Non-Steroidal [CS] |
Recall Initiation Date | 20220629 |
Report Date | 20220727 |
Classification Date | 20220718 |
Address | 750 Corporate Dr Mahwah, NJ 07430-2009 United States |
Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
Initial Notification | Letter |
Unique Ingredient Identifier | R16CO5Y76E 64ALC7F90C |
Drug Application Number | ANDA210318 |
Structured Product Labeling (SPL ID) | 0d676f72-27b7-48b8-aee0-8ce4be845956 |
Structured Product Labeling (SPL Set ID) | 467d6ce3-bc05-4aa1-87cc-3214fd628d39 |
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