RecallDepth
Class II Terminated

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

Company
Hetero Labs, Ltd. - Unit Iii
Recall Initiated
January 10, 2018
Posted
February 14, 2018
Recall Number
D-0594-2018
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
3000 bottles
Firm Location
Hyderabad, India

Reason for Recall

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

Distribution

NJ Only

Lot / Code Info

Lot #: ARI17089, ARI17090, Exp. 5/2019

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