C-*Vancomycin Opthal 14 mg drops recalled over sterility concerns

Recall date

March 13, 2020

Source

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

Official notice title

Medical Center Pharmacy, Inc. recalls C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311…

Recall number

D-1074-2020

FDA classification

Class II

Brand / firm

Medical Center Pharmacy, Inc.

Sold / distributed

Specific prescriptions to patients in TN

Why it was recalled

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

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

What was recalled

C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.