Why it was 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.
Product description
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
Lot numbers, UPCs & expiration codes
Lot 7B71A, Exp 01/2020
Where it was sold
Nationwide USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0993-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 22, 2019
- FDA report date
- Mar 20, 2019
- Quantity
- 51,456 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0993-2019, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 82200
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot 7B71A, Exp 01/2020
- Postal code
- 60045-4862
- Report date
- Mar 20, 2019
- Product type
- Drugs
- Recall number
- D-0993-2019
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 51,456 bottles
- Termination date
- Aug 9, 2022
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Feb 22, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 11, 2019