FDA Recall D-0668-2022
Blaine Labs Inc · Santa Fe Springs, CA
Class I — life-threatening Terminated 188 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0668-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide in 17 States to 45 doctors.
- Recall initiated
- 2022-01-25
- Classified by FDA Center
- 2022-03-18
- FDA published
- 2022-03-30
- Terminated
- 2022-08-01
- Recalling firm
- Blaine Labs Inc
- Firm location
- Santa Fe Springs, CA
Drug identification
- Brand name(s)
- REVITADERM WOUND CARE
- Generic name(s)
- BENZALKONIUM CHLORIDE
- Manufacturer(s)
- Blaine Labs Inc.
- NDC(s)
63347-120- Route(s)
- TOPICAL