January 2018 FDA Recall Aripiprazole by American Health Packaging
D-0595-2018 - CGMP Deviations
This Class II drug recall was voluntarily initiated by American Health Packaging on January 19, 2018 for the product Aripiprazole. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0595-2018
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
01-19-2018
02-21-2018
270 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AMERICAN HEALTH PACKAGING
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
03-14-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : 174096, Exp 05/31/19
