Recalls / Class II
Class IID-0114-2021
Product
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
- Affected lot / code info
- Lots: T02520, T02637, exp 02/2021
Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution.
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, N/A, Livonia, Michigan 48152-3951
Distribution
- Quantity
- 841 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-11-18
- FDA classified
- 2020-12-01
- Posted by FDA
- 2020-12-09
- Terminated
- 2023-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0114-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.