Drug recall D-0668-2022
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.
Lots and codes
Lot/Batch #: BL 2844, Expiration date 2/19/2023
Recall details
- Recalling firm
- Blaine Labs Inc, Santa Fe Springs, CA
- Quantity
- 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
- Distribution
- Nationwide in 17 States to 45 doctors.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 25, 2022
- Terminated
- August 1, 2022
Related products
- RevitaDERM Wound Care – drug information
- NDC 63347-120 RevitaDERM Wound Care · Benzalkonium Chloride 170 mg/89mL · Blaine Labs Inc.