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
Reported: October 31, 2018 Initiated: August 6, 2018 #D-0102-2019
Product Description
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
Reason for Recall
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- N/A
- Distribution
- Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA. Units affected: N/A.
Why was this product recalled? ▼
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0102-2019.
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