# FDA recall D-0668-2022

> **Blaine Labs Inc** · Class I · drug recall initiated 2022-01-25.

## Product

REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670

## Reason for recall

Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.

## Distribution

Nationwide in 17 States to 45 doctors.

## Key facts

- **Recall number:** D-0668-2022
- **Recalling firm:** Blaine Labs Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-25
- **Report date:** 2022-03-30
- **Termination date:** 2022-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Fe Springs, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0668-2022

## Citation

> AI Analytics. FDA recall D-0668-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0668-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*