# FDA recall D-0533-2020

> **Fagron, Inc** · Class II · drug recall initiated 2019-10-31.

## Product

LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel:  Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription Compounding, Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120.  NDC: 51552-1539-1

## Reason for recall

Microbial contamination of non-sterile product.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0533-2020
- **Recalling firm:** Fagron, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-31
- **Report date:** 2019-12-11
- **Termination date:** 2020-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0533-2020

## Citation

> AI Analytics. FDA recall D-0533-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-0533-2020. Source: US FDA. Licensed CC0.

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