Why it was recalled
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Product description
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
Lot numbers, UPCs & expiration codes
Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020
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-0414-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 8, 2018
- FDA report date
- Feb 6, 2019
- Quantity
- 149,159 5mL bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0414-2019, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 81193
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020
- Postal code
- 60045-4862
- Report date
- Feb 6, 2019
- Product type
- Drugs
- Recall number
- D-0414-2019
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 149,159 5mL bottles
- Termination date
- Jun 15, 2022
- Reason for recall
- Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Oct 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 28, 2019