Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Ph
Summary
The FDA issued a Class III for Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle by Glenmark Pharmaceuticals Inc., USA. Reason: Failed Tablet/Capsule Specification : Capsule breakage.
Details
Source
Drug Recall
External ID
D-1282-2022
Action Date
2022-07-27
Status
Ongoing
Category
drug
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.
Lot/Code Info: 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 Affected: 168936 bottles
Reason for Recall
Failed Tablet/Capsule Specification : Capsule breakage
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-29
Company
Mahwah, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 115 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Glenmark Pharmaceuticals Inc., USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Glenmark Pharmaceuticals Inc., USA have FDA actions?
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1282-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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