FDAFDA · Food and drugs·Recall number D-1878-2019
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Published October 2, 2019 · Recall initiated: September 17, 2019
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: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide within the United States and Puerto Rico
- Lot
- Lot #: 9B21A, Exp. 1/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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