Inspections, Compliance, Enforcement, and Criminal Investigations
Revival Animal Health, Inc. Warning Letter FDA Response
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Kansas City District
11630 West 80 Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100
March 7, 2006
Revival Animal Health, Inc.
1700 Albany Place SE
Orange City, Iowa 51041
Dear Mr. Funk:
This letter acknowledges receipt of your December 16, 2005 response to the Warning Letter issued to your firm by the Food and Drug Administration on November 21, 2005 (KAN 2006-03).
A review of the website revisions, included with your response, has been completed and we have to following comments :
Epinephrine Injectable: identified as 1 :1001, should be corrected to read 1 :1000. Information regarding the prescription requirement for the 30 ml vial size should be included on the webpage. The regulation found in 21 CFR 500.65(b) requires a prescription to dispense the 30 ml vial size of this product. The 10 ml size can be sold without a prescription.
Lincocin Injectable: The product displayed is the over the counter (OTC) strengths for swine use. The use of lincomycin injectable requires a prescription for use in dogs and cats, per 21 CFR 522.1260(e)(1)(iii). This is considered advertising extra label use of approved products and is not permitted per 21 CFR 530.4.
Pyrantel 50 mg: The product pictured is the "PAMIX" brand of pyrantel palmoate suspension and is a human use product for the treatment of pinworms. The advertising of human products for use in animals is considered extra label use and is not permitted per 21 CFR 530.4. There are approved products on the market for use on dogs and horses, see 21 CFR 520.2043.
Albon Soluble Powder: The product pictured, manufactured by [redacted] is for treatment of poultry and cattle. Promoting the extra label use of an approved product for other animals is not allowed per 21 CFR 530.4.
An example of other extra label use advertised on your website, www.revivalanimal.com, is the parasite control for cats. By going to Shop By Animal - Cats, Subcatagories - Parasite Control for Cats, one is taken to the following webpages:
SafeGuard: "same as Panacur, but labeled for cattle"
Albon 12.5% Solution: "labeled for poultry and cattle"
Pyrante150 mg : Picture shows the human use product "PAMIX"
You should review your entire product inventory and advertising (both internet and catalog) for compliance with the regulations. Certain products require a prescription for use in companion animals. Products sold OTC for specific animals cannot be advertised for extra label use. Approved human use products cannot be advertised for extra label use in animals.
From the telephone conference call held December 20, 2005, you indicated follow up with this office in 30 days . We have not received any additional information since that phone call. Please provide us with an update on the status of your corrective actions.
Joseph G. Kramer
Kansas City District