Lidocaine Hydroclhoride Jelly USP recall: Particulate Matter
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Why was Lidocaine Hydroclhoride Jelly USP recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 9B21A, Exp. 1/2022
- Product
- Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
- Recalling firm
- Akorn, Inc.
- Quantity
- 10,543 tubes
- Distribution
- Nationwide within the United States and Puerto Rico
- Recall date
- October 2, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)