Hetero Labs, Ltd. - Unit III recalls Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway,
Recalled February 14, 2018 · FDA recall D-0594-2018 · Hetero Labs, Ltd. - Unit III
Hazard
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. · FDA Class II
Units
3000 bottles
Sold at
NJ Only
Description
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
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
Manufacturer(s)
Hetero Labs, Ltd. - Unit III
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →