Class II · Moderate risk Ongoing
Aripiprazole Tablets USP
Reason Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Aripiprazole Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Superpotent Drug; out of specification results for assay (manufacturer)
What was recalled
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
- Recalling firm
- The Harvard Drug Group
- NDC code
- 0904-6509-04
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0692-2017
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.
Other Aripiprazole recalls
See all
Class II · Moderate risk Ongoing
Aripiprazole Tablets
Reason Superpotent drug
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
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