FDA-Drug2018-10-31Class II

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

Teva Pharmaceuticals USA
Hazard

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Sold states
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Affected count
N/A
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0102-2019

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