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
Product summary
- 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
out of specification