Drug & medication recalls Moderate risk

Takeda Development Center Americas, Inc. recalls Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, D…

Recall date
September 10, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0026-2019
FDA classification
Class II
Brand / firm
Takeda Development Center Americas, Inc.
Sold / distributed
AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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