FDAJune 26, 2015drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

apothecary shoppeapothecary

UPCs

13452277494

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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