Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Reported: February 21, 2018 Initiated: January 19, 2018 #D-0595-2018
Product Description
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Reason for Recall
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Details
- Recalling Firm
- AMERICAN HEALTH PACKAGING
- Units Affected
- 270 cartons
- Distribution
- Nationwide in the USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.. Recalled by AMERICAN HEALTH PACKAGING. Units affected: 270 cartons.
Why was this product recalled? ▼
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 21, 2018. Severity: Moderate. Recall number: D-0595-2018.
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