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
Reported: August 21, 2019 Initiated: March 1, 2019 #D-1820-2019
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.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 13,229 cartons
- Distribution
- Nationwide USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by American Health Packaging. Units affected: 13,229 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1820-2019.
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