Blaine Labs Inc: Drug Recall
Recall #D-0668-2022 · 01/25/2022
Class I: Dangerous
Recall Details
- Recall Number
- D-0668-2022
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Blaine Labs Inc
- Status
- Terminated
- Date Initiated
- 01/25/2022
- Location
- Santa Fe Springs, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
Reason for Recall
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
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
Distribution Pattern
Nationwide in 17 States to 45 doctors.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.