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Low RiskFDA Vet
Pets & Animals/Pet Medications

Ceva Animal Health, LLC: Various Animal Shampoos, Flushes, and Sprays Recalled for Stability Failure

Agency Publication Date: June 11, 2019
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Summary

Ceva Animal Health, LLC is recalling 130,365 bottles of various veterinary skin care products, including Ketoseb + PS, PhytoVet, Suffusion, VetraSeb, Chlorhexidine 4%, Dermachlor, BPO PS, Oxiderm, SkinGuard, Pramoderm, and Pramosoothe. These animal shampoos, antiseptic flushes, and medicated sprays were found to have active ingredients that failed to maintain their required strength and stability levels throughout their expected shelf life. This nationwide recall affects products sold in 4-oz, 8-oz, and 16-oz bottles distributed through major veterinary suppliers like Henry Schein, Patterson Veterinary, and MWI.

Risk

The failure of active ingredients to meet stability specifications means the products may not be as effective as intended for treating the animal's skin condition. If the medication levels are lower than required, the animal's underlying infection or skin irritation may not resolve, potentially leading to prolonged discomfort or worsening of the condition.

What You Should Do

  1. Identify your product by checking the brand name and bottle size on the label. Affected brands include Ketoseb + PS, PhytoVet, Suffusion, VetraSeb, Dermachlor, Oxiderm, SkinGuard, Pramoderm, and Pramosoothe.
  2. Check the lot number printed on your bottle against the affected list. For example, Ketoseb + PS 4-oz lots include 170765A, 170546A, 170206B, 170083B, 161306D, and 161306C; PhytoVet CK 4-oz lots include 170944A, 170765B, 170546B, 170206A, 170083A, 161306B, and 171027.
  3. Verify the SKU on the packaging. For Ketoseb 4-oz use FSKEPS2004; for Dermachlor 8-oz use FSCHH00008HS; for Suffusion HC Spray use FSRHC000108.PA.
  4. Contact your veterinarian, healthcare provider, or pharmacist to discuss alternative treatments for your pet's skin condition.
  5. Return any unused or partially used bottles to the place of purchase (such as your veterinary clinic or the distributor) for a refund.
  6. Contact Ceva Animal Health, LLC at their Lenexa, Kansas headquarters for further instructions regarding this voluntary recall.
  7. For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Voluntary recall refund or exchange guidance.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ketoseb + PS Flush (4 and 16oz)
Model:
FSKEPS2004
FSKEPS2016
Lot Numbers:
170765A
170546A
170206B
170083B
161306D
161306C
170765C
170371C
170083C
161306F
Product: PhytoVet CK Antiseptic Flush (4 and 16oz)
Model:
FSKEPS2004HS
FSKEPS2016HS
Lot Numbers:
170944A
170765B
170546B
170206A
170083A
161306B
171027
170944D
170765D
170371D
170083D
Product: Suffusion K+PS Flush (4 and 16oz)
Model:
FSKEPS2004PA
FSKEPS2016PA
Lot Numbers:
170371A
170944B
170371B
170944C
Product: VetraSeb CK Flush (4 and 16oz)
Model:
FSKEP2004MW
FSKEPS206MW
Lot Numbers:
161306A
161306E
Product: Chlorhexidine 4% HC Shampoo (8 and 16oz)
Model:
FSCHH00008CL
FSCHH00016CL
Lot Numbers:
170133A
170933A
170788A
Product: Dermachlor HC Shampoo (8 and 16oz)
Model:
FSCHH00008HS
FSCHH00016HS
Lot Numbers:
170133B
170933B
171283
170788B
Product: BPO PS Shampoo (8 and 16oz)
Model:
FSOXYPS1008MV
FSOXYPS1016MV
Lot Numbers:
170089B
170374C
170529B
170630B
170374G
170529E
170630E
Product: Oxiderm + PS Shampoo (8 and 16oz)
Model:
FSOXYPS1008CL
FSOXYPS1016CL
Lot Numbers:
170089B
170374C
170529B
170630B
70900A
170374G
170529E
170630E
Product: PhytoVet PSS Antiseborrheic Shampoo (8 and 16oz)
Model:
FSOXYPS1008HS
FSOXYPS1016HS
Lot Numbers:
170089A
170630A
170900C
170089C
170529D
170630F
170900D
Product: SkinGuard with Phytosphingosine (8oz)
Model:
F41910ECV
Lot Numbers:
170374A
170374B
Product: Suffusion A+PS Shampoo (8 and 16oz)
Model:
FSOXYPS1008PA
FSOXYPS1016PA
Lot Numbers:
170374E
170900B
170374F
Product: VetraSeb SSB Shampoo (8 and 16oz)
Model:
FSOXYPS1008MW
FSOXYPS1016MW
Lot Numbers:
161378A
170374D
170529C
170630C
161378B
Product: Pramoderm HC Spray (8oz)
Model:
FSRHC000108.HS
Lot Numbers:
170035A
170153C
170545A
171017A
171285B
Product: Pramosoothe HC Spray (8oz)
Model:
FSRHC000108
FSRHC000108.CL
Lot Numbers:
170035B
170153A
170153B
170397C
170545C
171285A
Product: Skin Soothing HC Spray (8oz)
Model:
FSRHC000108.PA
Lot Numbers:
170153B
170397C
170545C
171285A
Product: Suffusion HC Spray (8oz)
Model:
FSRHC000108.PA
Lot Numbers:
170397A
171017B
Product: VetraSeb HC Spray (8oz)
Model:
FSRHC000108.MW
Lot Numbers:
170397B
170545B

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81791
Status: Resolved
Manufacturer: Ceva Animal Health, LLC
Sold By: Henry Schein Animal Health; Patterson Veterinary; MWI
Manufactured In: United States
Units Affected: 17 products (8,732 bottles; 28,816 bottles; 2,869 bottles; 4,469 bottles; 996 bottles; 10,961 bottles; 999 bottles; 23,548 bottles; 17,629 bottles; 3,252 bottles; 4,196 bottles; 7,267 bottles; 8,037 bottles; 5,914 bottles; 217 bottles; 1,561 bottles; 902 bottles)
Distributed To: Nationwide
Agency Last Updated: June 20, 2019

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response