PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: September 14, 2016 Initiated: June 17, 2016 #D-1496-2016

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

Details

Recalling Firm
Teva North America
Units Affected
14,661 vials
Distribution
Nationwide and Puerto Rico
Location
Horsham, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Teva North America. Units affected: 14,661 vials.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on September 14, 2016. Severity: Moderate. Recall number: D-1496-2016.