Deerfield, IL, United States
Takeda Development Center Americas, Inc. recalls
2 recalls recorded since 2018, most recently on 6 November 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 6 November 2018
- Terminated
- 20 June 2019
- Reason
- Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
- Distribution
- Product was distributed to 32 distributors throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0286-2019
- AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan
Terminated Class II Drugs
- Recall started
- 10 September 2018
- Terminated
- 13 April 2020
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0026-2019
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.