FDA Drug recall D-1878-2019
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045
- FDA Drug
- Class II
- terminated
- Published 2019-10-02
On 2019-10-02 the FDA classified a Class II recall of Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045 by Akorn, citing 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 identifi….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1878-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-17 |
| Published | 2019-10-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
Product
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Reason
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.
Identifiers
| code_info | Lot #: 9B21A, Exp. 1/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1878-2019%22
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