FDA-Drug2018-10-17Class II

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

Takeda Development Center Americas, Inc.
Hazard

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.

Sold states
AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico
Affected count
7,248 bottles
Manufactured in
1 Takeda Pkwy, 4034BB1, Deerfield, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0026-2019

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