FDA-Drug2019-02-20Class II

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

Promise Pharmacy, LLC
Hazard

Lack of sterility assurance.

Sold states
Nationwide in the USA.
Affected count
75 10 ml bottles
Manufactured in
31818 Us Highway 19 N, N/A, Palm Harbor, FL, United States
Products
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0431-2019

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