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

FDA recall notice · announced February 14, 2018 · Hetero Labs, Ltd. - Unit Iii

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

Reason for recall

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

Notes

Distribution: NJ Only
Lot/code information: Lot #: ARI17089, ARI17090, Exp. 5/2019
Quantity: 3000 bottles
Status: Terminated
Products in this recall event:
- 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 Nag (D-0594-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.