PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass; Multiple...
FDA Recall #D-0775-2017 — Class II — April 18, 2017
Product Description
PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL 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
1 vial
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot t# 02-14-2017@102, Exp 5/1/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated