Recalls / Class III
Class IIID-0692-2017
Product
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
- Affected lot / code info
- LOT: T-00601 Exp: 04-2017
Why it was recalled
Superpotent Drug; out of specification results for assay (manufacturer)
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, Livonia, Michigan 48152-3951
Distribution
- Quantity
- 36,990 tablets
- Distribution pattern
- Nationwide and PR
Timeline
- Recall initiated
- 2016-12-27
- FDA classified
- 2017-05-02
- Posted by FDA
- 2017-05-10
- Terminated
- 2017-07-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0692-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.