Drug 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
D-0668-2022
Product summary
- Firm
- Blaine Labs Inc
- Event
- Event 89481
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
- Official record key
drug-enforcement:D-0668-2022
Official wording
Reason: Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Code information: Lot/Batch #: BL 2844, Expiration date 2/19/2023
Distribution pattern: Nationwide in 17 States to 45 doctors.
Derived failure modes
-
Microbial contamination
Microbial Contamination