FDA recall D-1820-2019

Product

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

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2019-03-01

Report date

2019-08-21

Termination date

2020-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

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