January 2022 FDA Recall Revitaderm Wound Care by Blaine Labs Inc
D-0668-2022 - Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.

This Class I drug recall was voluntarily initiated by Blaine Labs Inc on January 25, 2022 for the product Revitaderm Wound Care. The FDA reported the reason for recall as microbial contamination of non-sterile product; fda analysis found the product to be contaminated with bacillus cereus.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0668-2022

Reason for Recall
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Initiated
01-25-2022
Reported
03-30-2022
Quantity
1119 (1 oz.) bottles/ 772 (3 oz.) tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89481
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Blaine Labs Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in 17 States to 45 doctors.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-01-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot/
Lot# : BL 2844, Expiration date 2/19/2023

Affected Packages Involved in this Recall

63347-120-01 Revitaderm Wound Care
63347-120-02 Revitaderm Wound Care