FDA-Drug2017-05-10Class III

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

The Harvard Drug Group
Hazard

Superpotent Drug; out of specification results for assay (manufacturer)

Sold states
Nationwide and PR
Affected count
36,990 tablets
Manufactured in
17177 N Laurel Park Dr Ste 233, Livonia, MI, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0692-2017

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