Gentamicin Sulfate Ophthalmic Solution recall: Particulate Matter
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
Why was Gentamicin Sulfate Ophthalmic Solution recalled?
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
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?
Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020
- Product
- Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
- Recalling firm
- Akorn, Inc.
- Quantity
- 149,159 5mL bottles
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- February 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)