D-1820-2019 Class II Terminated
FDA drug recall D-1820-2019 was initiated by American Health Packaging on March 1, 2019 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples. The recall status is terminated (terminated September 30, 2020). Affected quantity: 13,229 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- August 21, 2019
- Initiation Date
- March 1, 2019
- Termination Date
- September 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,229 cartons
Product Description
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 Pattern
Nationwide USA
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