FDAFDA · Food and drugs·Recall number D-1495-2022
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
Published September 14, 2022 · Recall initiated: August 31, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- USA nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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