Class II
Terminated
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
- Company
- Akorn, Inc
- Recall Initiated
- August 31, 2022
- Posted
- September 14, 2022
- Recall Number
- D-1495-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 82,689 tubes
- Firm Location
- Gurnee, IL, United States
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.
Distribution
USA nationwide
Lot / Code Info
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
More recalls by Akorn, Inc
Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Fo...
Jun 7, 2023 · Class II
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Steri...
Feb 15, 2023 · Class III
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc.,...
Jan 25, 2023 · Class II
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026