D-0594-2018 Class II Terminated
FDA drug recall D-0594-2018 was initiated by Hetero Labs, Ltd. - Unit III on January 10, 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 September 21, 2020). Affected quantity: 3000 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 14, 2018
- Initiation Date
- January 10, 2018
- Termination Date
- September 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3000 bottles
Product Description
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
Reason for Recall
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Distribution Pattern
NJ Only
Code Information
Lot #: ARI17089, ARI17090, Exp. 5/2019