January 2018 FDA Recall Aripiprazole by Hetero Labs, Ltd. - Unit Iii
D-0594-2018 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Hetero Labs, Ltd. - Unit Iii on January 10, 2018 for the product Aripiprazole. The FDA reported the reason for recall as cgmp deviations. The product was distributed in NJ Only and the recall is currently terminated.
Recall Number: D-0594-2018
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
01-10-2018
02-14-2018
3000 bottles
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.
Hetero Labs, Ltd. - Unit III
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.
NJ Only
09-21-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
Batch or Lot Expiration Information
Lot# : ARI17089, ARI17090, Exp. 5/2019
