D-0595-2018 Class II Terminated
FDA drug recall D-0595-2018 was initiated by AMERICAN HEALTH PACKAGING on Jan 19, 2018 and is designated Class II. Reason for recall: CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. The recall status is terminated (terminated Mar 14, 2019). Affected quantity: 270 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 21, 2018
- Initiation Date
- Jan 19, 2018
- Termination Date
- Mar 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270 cartons
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 174096, Exp 05/31/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0595-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026