Acetylcysteine Ophthalmic Solution recall: Sterility Concern
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
Why was Acetylcysteine Ophthalmic Solution recalled?
Lack of sterility assurance.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 11072018@10 BUD: 12/22/2018
- Product
- Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
- Recalling firm
- Promise Pharmacy, LLC
- Quantity
- 75 10 ml bottles
- Distribution
- Nationwide in the USA.
- Recall date
- February 20, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)