Recalls / Class II
Class IID-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
- Affected lot / code info
- 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
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 13,229 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2019-03-01
- FDA classified
- 2019-08-15
- Posted by FDA
- 2019-08-21
- Terminated
- 2020-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1820-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.