BENZALKONIUM CHLORIDE Recall D-0668-2022
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
BENZALKONIUM CHLORIDE Recall D-0668-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0668-2022 |
| Event ID | 89481 |
| Brand | REVITADERM WOUND CARE |
| Generic Name | BENZALKONIUM CHLORIDE |
| Manufacturer | BENZALKONIUM CHLORIDE |
| Original Package? | 1 |
| Active Substance | BENZALKONIUM CHLORIDE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in 17 States to 45 doctors. |
| Quantity | 1119 (1 oz.) bottles/ 772 (3 oz.) tubes |
| Recall Reason | Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus. |
| Drug Classification | Class I |
| Drug Code Info | 20220330 |
| Product NDC | 63347-120 |
| Recall Initiation Date | 20220125 |
| Report Date | 20220330 |
| Classification Date | 20220318 |
| Address | 11037 Lockport Pl Santa Fe Springs, CA 90670-4634 United States |
| Recalling Firm | Blaine Labs Inc |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | F5UM2KM3W7 |
| Drug Application Number | part333A |
| Structured Product Labeling (SPL ID) | bd77ff71-06a1-46e7-946b-2e0336716538 |
| Structured Product Labeling (SPL Set ID) | 9254dada-4e32-43a0-892b-c488d68e23e7 |
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