PGE1/PROCAINE MDV 40MCG/ML/0 recalled over sterility concerns

Recall date

April 18, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Key Pharmacy and Compounding Center recalls PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by…

Recall number

D-0757-2017

FDA classification

Class II

Brand / firm

Key Pharmacy and Compounding Center

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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