Acetylcyst 10% OPHT SOL recalled over sterility concerns

Recall date

July 7, 2016

Source

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

Official notice title

Medicap Pharmacy recalls Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 9999…

Recall number

D-1447-2016

FDA classification

Class II

Brand / firm

Medicap Pharmacy

Sold / distributed

ID

Why it was recalled

Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.

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

What was recalled

Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.