Recalls / Class II
Class IID-0026-2019
Product
Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30
- Affected lot / code info
- Lot, expiry: A26004, exp Apr 2020; A26443 and A26444, exp Sep 2020
Why it was recalled
Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Recalling firm
- Firm
- Takeda Development Center Americas, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Takeda Pkwy, 4034BB1, Deerfield, Illinois 60015-5713
Distribution
- Quantity
- 7,248 bottles
- Distribution pattern
- AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico
Timeline
- Recall initiated
- 2018-09-10
- FDA classified
- 2018-10-15
- Posted by FDA
- 2018-10-17
- Terminated
- 2020-04-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0026-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.