PROCAINE HCL SDV 1% INJ 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 PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Com…

Recall number

D-0773-2017

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

PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy