FDA recall D-1282-2022

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.

Reason for recall

Failed Tablet/Capsule Specification : Capsule breakage

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2022-06-29

Report date

2022-07-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1282-2022