Drug recall D-0594-2018
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
Reason for recall
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Lots and codes
Lot #: ARI17089, ARI17090, Exp. 5/2019
Recall details
- Recalling firm
- Hetero Labs, Ltd. - Unit III, Hyderabad, N/A
- Quantity
- 3000 bottles
- Distribution
- NJ Only
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 10, 2018
- Terminated
- September 21, 2020
Related products
- Aripiprazole – drug information
- NDC 31722-828 Aripiprazole · Aripiprazole 15 mg/1 · Camber Pharmaceuticals, Inc.
- NDC 31722-819 Aripiprazole · Aripiprazole 2 mg/1 · Camber Pharmaceuticals, Inc.
- NDC 31722-830 Aripiprazole · Aripiprazole 30 mg/1 · Camber Pharmaceuticals, Inc.
- NDC 31722-827 Aripiprazole · Aripiprazole 10 mg/1 · Camber Pharmaceuticals, Inc.
- NDC 31722-829 Aripiprazole · Aripiprazole 20 mg/1 · Camber Pharmaceuticals, Inc.
- NDC 31722-820 Aripiprazole · Aripiprazole 5 mg/1 · Camber Pharmaceuticals, Inc.