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Recall Observatory FDA recall evidence

Drug 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

D-1820-2019

March 01, 2019

Class II

Product summary

Firm
American Health Packaging
Event
Event 83479
Status
Terminated
Classification
Class II
Quantity
13,229 cartons
Official record key
drug-enforcement:D-1820-2019

Official wording

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

Code information: Lot, expiry: Lot 174262, exp. 03/31/2019; Lot 176469, exp. 06/30/2019; Lot 177897, exp. 08/31/2019; Lots 178318 and 178436, exp. 09/30/2019; Lot 179547 and 179656, exp. 11/30/2019

Distribution pattern: Nationwide USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification