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Antiplatelet Agent Recalled


August 22, 2019

An unknown purity detected in product samples has prompted American Health Packaging to recall more than a half-dozen lots aspirin and extended-release dipyridamole capsules, according to the August 21, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall spans 13,229 cartons (carton NDC 60687-305-32) of aspirin and extended-release dipyridamole capsules, 25 mg/200 mg, each containing five 4-dose blister packs (blister pack NDC 60687-305-33). The affected tablets are from lots 174262 (Exp. 3/31/19), 176469 (Exp. 6/30/19), 177897 (Exp. 8/31/19), 178318 and 178436 (Exp. 9/30/19), and 179547 and 179656 (Exp. 11/30/19). The recalled tablets were distributed throughout the United States. 

American Health Packaging voluntarily initiated the recall March 1, 2019, according to the FDA Enforcement Report. On August 15, 2019, the FDA designated the recall Class II. The classification suggests use of the product could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.

Aspirin and extended-release dipyridamole is a prescription antiplatelet agent used to reduce the risk of stroke in people who have had blood clots or transient ischemic attacks. 

Jolynn Tumolo

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