SO-Acetylcysteine 10% Sterile Ophthalmic Solution recalled over sterility concerns

Recall date

June 26, 2015

Source

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

Official notice title

The Apothecary Shoppe LLC recalls SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tuls…

Recall number

D-1312-2015

FDA classification

Class II

Brand / firm

The Apothecary Shoppe LLC

Sold / distributed

Oklahoma

Why it was recalled

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

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

What was recalled

SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94