Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Reason Superpotent drug
Reason Cross Contamination with Other Products
Reason Cross Contamination with Other Products
Reason Cross Contamination with Other Products
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