Class II
Terminated
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.
This recall has been terminated (originally issued February 21, 2018).
- Company
- American Health Packaging
- Recall Initiated
- January 19, 2018
- Posted
- February 21, 2018
- Recall Number
- D-0595-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 270 cartons
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: 174096, Exp 05/31/19
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