Gentamicin Sulfate Ophthalmic Solution recall: Impurity Out of Spec
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
Why was Gentamicin Sulfate Ophthalmic Solution recalled?
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
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 7B71A, Exp 01/2020
- Product
- Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
- Recalling firm
- Akorn, Inc.
- Quantity
- 51,456 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- March 20, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)