D-1496-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 14, 2016
- Initiation Date
- June 17, 2016
- Termination Date
- February 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,661 vials
Product Description
Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
Reason for Recall
CGMP Deviations
Distribution Pattern
Nationwide and Puerto Rico
Code Information
All Lots Within Expiry Lot# 2710715, 2720715, 2730715, 3110715, 3120715