FOLINIC ACID MDV 5MG/ML 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 FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, P…

Recall number

D-0718-2017

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

FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy