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Takeda Development Center Americas Recalls
2 recalls on record · October 17, 2018 to November 21, 2018 · Drugs
November 21, 2018DrugsFDA
Takeda Development Center Americas, Inc. recalls AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD
Hazard: Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
October 17, 2018DrugsFDA
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, Di
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.