# FDA recall D-1878-2019

> **Akorn, Inc.** · Class II · drug recall initiated 2019-09-17.

## 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 for recall

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.

## Distribution

Nationwide  within the United States and Puerto Rico

## Key facts

- **Recall number:** D-1878-2019
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-09-17
- **Report date:** 2019-10-02
- **Termination date:** 2022-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1878-2019

## Citation

> AI Analytics. FDA recall D-1878-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-1878-2019. Source: US FDA. Licensed CC0.

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