D-0730-2017 Class II Terminated

Recalled by Key Pharmacy and Compounding Center — Federal Way, WA

Recall Details

Product Type
Drugs
Report Date
May 24, 2017
Initiation Date
April 18, 2017
Termination Date
August 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 vials

Product Description

PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Reason for Recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Distribution Pattern

Distributed nationwide in U.S.A., Australia and Canada.

Code Information

Lot # t12-21-2016@110, Exp 6/20/2017; t12-27-2016@84, Exp 6/26/2017; t12-30-2016@74, Exp 7/2/2017.