Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Special...
FDA Recall #D-0431-2019 — Class II — December 17, 2018
Product Description
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
Reason for Recall
Lack of sterility assurance.
Recalling Firm
Promise Pharmacy, LLC — Palm Harbor, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
75 10 ml bottles
Distribution
Nationwide in the USA.
Code Information
Lot: 11072018@10 BUD: 12/22/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated