Class II
Terminated
Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.
This recall has been terminated (originally issued March 15, 2017).
- Company
- Endo Pharmaceuticals, Inc.
- Recall Initiated
- February 22, 2017
- Posted
- March 15, 2017
- Recall Number
- D-0512-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,086 cartridges
- Firm Location
- Malvern, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: 207386, Exp. May 2019
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