D-0757-2017 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

PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL 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 # t11-28-2016@86, Exp 5/22/2017; t12-19-2016@73, Exp 5/22/2017