Recalls / Class II
Class IID-0595-2018
Product
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.
- Brand name
- Aripiprazole
- Generic name
- Aripiprazole
- Active ingredient
- Aripiprazole
- Route
- Oral
- NDCs
- 60687-157, 60687-168, 60687-179, 60687-191, 60687-202, 60687-213
- FDA application
- ANDA205064
- Affected lot / code info
- Lot #: 174096, Exp 05/31/19
Why it was recalled
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Recalling firm
- Firm
- AMERICAN HEALTH PACKAGING
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 270 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-01-19
- FDA classified
- 2018-03-13
- Posted by FDA
- 2018-02-21
- Terminated
- 2019-03-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0595-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.