Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1282-2022
Event ID90543
BrandASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE
Generic NameASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE
ManufacturerASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE
Original Package?1
Active SubstanceASPIRIN DIPYRIDAMOLE
Drug RouteORAL
DistributionUSA Nationwide
Quantity168936 bottles
Recall ReasonFailed Tablet/Capsule Specification : Capsule breakage
Drug ClassificationClass III
Drug Code Info20220727
Product NDC68462-405
Product NUIN0000000160 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 Date20220629
Report Date20220727
Classification Date20220718
Address750 Corporate Dr
Mahwah, NJ 07430-2009
United States
Recalling FirmGlenmark Pharmaceuticals Inc., USA
Initial Notification Letter
Unique Ingredient IdentifierR16CO5Y76E 64ALC7F90C
Drug Application NumberANDA210318
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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