D-0668-2022 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 30, 2022
- Initiation Date
- January 25, 2022
- Termination Date
- August 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
Product Description
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 Pattern
Nationwide in 17 States to 45 doctors.
Code Information
Lot/Batch #: BL 2844, Expiration date 2/19/2023