Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30
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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