FDADecember 17, 2018drug

Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.

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

The hazard

Lack of sterility assurance.

What to do

FDA enforcement status: Terminated

Brands named

promise pharmacypromise

Recall history

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

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Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684. — Recall Details · AllClear