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
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactu...
Mckesson
· Feb 18, 2026
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLu...
Green Lumber Holdings, Llc
· Feb 11, 2026
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India...
Handelnine Global Llc
· Feb 11, 2026
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNat...
Medinatura New Mexico, Inc.
· Jan 14, 2026
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, L...
Fresenius Kabi Usa, Llc
· Dec 3, 2025