FDA-Drug2019-08-21Class II

Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33

American Health Packaging
Hazard

Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.

Sold states
Nationwide USA
Affected count
13,229 cartons
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1820-2019

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