PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL glass/Multiple Dos...
FDA Recall #D-0729-2017 — Class II — April 18, 2017
Product Description
PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/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.
Recalling Firm
Key Pharmacy and Compounding Center — Federal Way, WA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4 vials
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # t11-28-2016@111, Exp 5/28/2017; 02-10-2017@1, Exp 8/9/2017.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated