Recalls / Class II
Class IID-0102-2019
Product
PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015
- Affected lot / code info
- Bulk Lot no 1250668, 15 mg/1000 mg Bulk product No # 1274150, no NDC Codes, bulk exp. date 05/2020 & 10/2020
Why it was recalled
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- N/A
- Distribution pattern
- Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Timeline
- Recall initiated
- 2018-08-06
- FDA classified
- 2018-10-25
- Posted by FDA
- 2018-10-31
- Terminated
- 2020-02-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0102-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.