Pre-Op Pledget Soln + Tetracaine recalled over sterility concerns

Recall date

July 26, 2016

Source

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

Official notice title

Pharmacy Plus, Inc. dba Vital Care Compounder recalls Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxac…

Recall number

D-1543-2016

FDA classification

Class II

Brand / firm

Pharmacy Plus, Inc. dba Vital Care Compounder

Sold / distributed

MS

Why it was recalled

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

Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS