FDA-Drug2018-02-14Class II
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
Hetero Labs, Ltd. - Unit III
Hazard
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Sold states
NJ Only
Affected count
3000 bottles
Manufactured in
Plot 22-110, Part Ii, Ida, Rangareddy, Jeedimetla, Hyderabad, N/A, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0594-2018Don't want to check this manually?
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