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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot, expiry: A26004, exp Apr 2020; A26443 and A26444, exp Sep 2020
Where it was sold
AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0026-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 10, 2018
- FDA report date
- Oct 17, 2018
- Quantity
- 7,248 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Takeda Development Center Americas, Inc.
Original FDA data
Every field from FDA enforcement report D-0026-2019, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80964
- Address
- 1 Takeda Pkwy
- Address (line 2)
- 4034BB1
- Code information
- Lot, expiry: A26004, exp Apr 2020; A26443 and A26444, exp Sep 2020
- Postal code
- 60015-5713
- Report date
- Oct 17, 2018
- Product type
- Drugs
- Recall number
- D-0026-2019
- Classification
- Class II
- Recalling firm
- Takeda Development Center Americas, Inc.
- Product quantity
- 7,248 bottles
- Termination date
- Apr 13, 2020
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico
- Recall initiation date
- Sep 10, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 15, 2018