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WARNING LETTER

Pegasus Laboratories, Inc. MARCS-CMS 488027 —

Product:
Animal & Veterinary

Recipient:
Pegasus Laboratories, Inc.


United States

Issuing Office:
Florida District Office

United States


   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-16-20
August 5, 2016
 

 

 
Ms. Donna Logan
General Manager
Pegasus Laboratories, Inc.
8809 Ely Road
Pensacola, FL 32514
 
Dear Ms. Logan:
 
This letter concerns your firm’s marketing of several products for animals, including but not limited to, Canine Cameo™ Otic, Gastromate® and CitraVet®. The U.S. Food and Drug Administration (FDA) reviewed your product labeling and your website at the internet address www.prnpharmacal.com, where you promote and sell these products. We have determined that these products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, these products are unapproved new animal drugs and your marketing of them violates the FD&C Act.  
 
Statements on your website and product labeling that show these intended uses of your products include, but are not limited to, the following:
 
Cameo™ Otic (CANINE)
  • "CAMEO™ Otic is indicated for the control of malodorous ear discharges and exudates associated with certain bacteria (Pseudomonas aeruginosa, and Staphylococcus aureus) and yeast (Malassezia pachydermatis)."
  • "CAMEO Otic helps control chronic malodorous discharges caused by bacteria and yeast, which is often associated with other secondary symptoms, such as redness, pain, and itching."
  • "In seven days, the potent formulation of CAMEO Otic kills more than 99% of susceptible strains of yeast and bacteria, including pseudomonas — A higher kill percentage with just one weekly dose than other products that require up to two doses per day.”
  • "Unlike products containing antibiotics or steroids, Cameo Otic can be used to manage recurring otitis externa as needed."  
GastroMate® Canine IgY Plus Gel (CANINE)
  • “Use GastroMate Canine IgY to support the digestive systems of dogs and puppies during gut disturbances of known or unknown origin.”
  • “State-of-the-art Digestive Support for Non-specific Diarrhea in Puppies & Dogs” 
CitraVet®
  • “Published research has shown a marked increase of Urolithiasis (recurring urinary stones) especially calcium oxalate (CaOx) stones in both dogs and cats. Some increasingly popular breeds are most susceptible to these stones, as well as male dogs approaching middle age. In fact, the total number of pets at risk may be higher than documented. ... Pets at risk produce calcium and oxalate, which can lead to stone formation. Liver-flavored CitraVet® tablets contain 675 mg of potassium citrate to increase citrate levels in the bladder. Calcium then binds to the citrate instead of the oxalate, (which could result in the formation of calcium oxalate stones3). Other less common stones, such as urate and cystine, can also be controlled with the same mechanism.”
Because your productsare intended to prevent, mitigate or treat diseases in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321 (g)(1)(B)]. Moreover, these products are new animal drugs, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. They are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, the products are unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. 
 
This letter is not intended to be an all-inclusive review of your products.The above referenced products are only a sampling of the violative products you are currently marketing.   It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products. 
 
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made. 
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Randall L. Morris, Compliance Officer. If you have any questions about the contents of this letter, please contact Randall L. Morris at 407-475-4741 (phone) or 407-475-4768(fax).
 
 
Sincerely,
/S/
Susan M. Turcovski
Director, Florida District
 
 
Cc: 
 
Mr. Jeff Santosuosso
Vice-President and General Manager
PRN Pharmacal
8809 Ely Road
Pensacola, FL 32514
 
Mr. Donald Chew
President and CEO
PBI/Gordon Corporation
1217 W. 12th Street
Kansas City, MO 64101