Acetylcysteine 10% Ophtalmic recall: Sterility Concern
ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas…
Why was Acetylcysteine 10% Ophtalmic recalled?
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on 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 Numbers: 20150209@41 BUD: 10/2/2015, 20150909@2 BUD: 10/9/2015
- Product
- ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas…
- Recalling firm
- US Compounding Inc
- Quantity
- 3 dropper bottles
- Distribution
- Nationwide
- Recall date
- November 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)