Revitaderm Wound CARE GEL 0.1% Recall: Sterility Concern
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
What is the FDA recall status?
The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.
Why was Revitaderm Wound CARE GEL 0.1% recalled?
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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
Which lot codes, UPCs or models are affected?
Lot/Batch #: BL 2844, Expiration date 2/19/2023
- Agency record number
- 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
- Recalling firm
- Blaine Labs Inc
- Quantity
- 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
- Distribution
- Nationwide in 17 States to 45 doctors.
- Recall started
- January 25, 2022
- Report date
- March 30, 2022
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)