Why it was recalled
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Product description
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
Lot numbers, UPCs & expiration codes
Lot # 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, Exp 8/31/2022; 9K62A, 9K62B, 9K62C, Exp 9/30/2022; 9M04A, 9M04B, Exp 11/30/2022
Where it was sold
USA nationwide
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-1495-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 31, 2022
- FDA report date
- Sep 14, 2022
- Quantity
- 82,689 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1495-2022, exactly as published.
Show all FDA fields
- City
- Gurnee
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 90813
- Address
- 5605 Centerpoint Ct Ste A
- Code information
- Lot # 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, Exp 8/31/2022; 9K62A, 9K62B, 9K62C, Exp 9/30/2022; 9M04A, 9M04B, Exp 11/30/2022
- Postal code
- 60031-5278
- Report date
- Sep 14, 2022
- Product type
- Drugs
- Recall number
- D-1495-2022
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 82,689 tubes
- Termination date
- Jun 18, 2024
- Reason for recall
- cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
- Distribution pattern
- USA nationwide
- Recall initiation date
- Aug 31, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 6, 2022