Class II · Moderate risk
Revitaderm Wound Care
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
National Drug Code
Is NDC 63347-0120-01 recalled?
RevitaDERM Wound Care · 89 mL in 1 TUBE (63347-120-01)
Yes — this exact package was recalled
2 FDA recalls name the code 63347-0120-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
2 of these recalls are still ongoing.
- Active ingredient
- Benzalkonium Chloride
- Strength
- BENZALKONIUM CHLORIDE 170 mg/89mL
- Form
- Gel · Topical
- Labeler
- Blaine Labs Inc.
- Type
- Human OTC Drug
- Product code
- 63347-0120
Recalls naming this package
Class I · High risk
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Class I · High risk
Revitaderm Wound Care Gel
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 63347-0600 Terpenicol Antifungal 1
- 63347-0601 Terpenicol 1
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