REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 2
Summary
The FDA issued a Class I for REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transformi by Blaine Labs Inc. Reason: Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus..
Details
Source
Drug Recall
External ID
D-0668-2022
Action Date
2022-03-30
Status
Terminated
Category
drug
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
Lot/Code Info: Lot/Batch #: BL 2844, Expiration date 2/19/2023
Quantity Affected: 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.
Distribution
Nationwide in 17 States to 45 doctors.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-25
Company
Santa Fe Springs, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Blaine Labs Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Blaine Labs Inc have FDA actions?
This is the only FDA action we have on record for Blaine Labs Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0668-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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