RecallDepth
Class I Terminated

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

This recall has been terminated (originally issued March 30, 2022).

Company
Blaine Labs Inc
Recall Initiated
January 25, 2022
Posted
March 30, 2022
Recall Number
D-0668-2022
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
1119 (1 oz.) bottles/ 772 (3 oz.) tubes
Firm Location
Santa Fe Springs, CA, United States
Official Source
View on FDA website ↗

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.

Lot / Code Info

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

Other recent Class I Drug recalls