FDA recall D-0026-2019

Product

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

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.

Distribution

AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-09-10

Report date

2018-10-17

Termination date

2020-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

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