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Medium RiskFDA Vet
Pets & Animals/Pet Medications

TEVA Animal Health Inc: Various Veterinary Medicines Recalled for Manufacturing Standard Violations

Agency Publication Date: April 13, 2010
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Summary

TEVA Animal Health Inc. is recalling over 21.3 million units of various veterinary medications, including injectable solutions, oral liquids, shampoos, and dewormers, because they were not manufactured in compliance with Good Manufacturing Practices (GMP). These products were sold under multiple brand names such as AgriLabs, AmTech, Butler, DVM, and Phoenix Pharmaceutical. The failure to follow quality standards means these medications could have inconsistent potency, purity, or safety, potentially harming the animals they are intended to treat.

Risk

Failure to comply with manufacturing standards increases the risk of product contamination or incorrect dosage levels, which can lead to treatment failure or adverse health reactions in animals. Consumers should contact a veterinarian or pharmacist regarding any animals that have been treated with these medications.

What You Should Do

  1. Check your veterinary medicine supplies for any of the affected brands, which include AgriLabs, AmTech Group, Aspen, Butler, DVM, Durvet, Farnam, Horse Health, IVX, Phoenix Pharmaceutical, RXV, TEVA, and VEDCO.
  2. Identify your product using the specific Recall Numbers (V-077-2010 through V-168-2010) and product descriptions found on the packaging or labels.
  3. Immediately stop using the affected products on your animals and quarantine any remaining stock.
  4. Contact your veterinarian, healthcare provider, or pharmacist for guidance on alternative treatments and to report any health issues observed in your animals.
  5. Return any unused product to the place of purchase or pharmacy for a refund and contact the manufacturer for further disposal instructions.
  6. For additional questions or to report concerns, contact the FDA Consumer Complaint Coordinator in your state or call the FDA at 1-888-463-6332.

Your Remedy Options

💰Full Refund

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

How to: Consumers should stop using the products and contact their supplier or TEVA Animal Health for refund information.

Affected Products

Product: Butler Aminocal Plus Oral Solution (1,000-ml)
Model:
V-077-2010
Product: AmTech Group Amcal High Potency Oral Solution (1,000-ml)
Model:
V-077-2010
Product: AmTech Group Amino-Dex-Forte Oral Solution (1,000-ml)
Model:
V-078-2010
Product: AgriLabs Amino Acid Oral Solution (500-ml)
Model:
V-079-2010
Product: AgriLabs Amino Acid Concentrate Oral Solution (500-ml)
Model:
V-080-2010
Product: AgriLabs Neomycin Oral Solution (1-gal and 1-pt)
Model:
V-081-2010
Product: AmTech Group Anthelban V Equine Suspension (1-pt and 1-qt)
Model:
V-082-2010
Product: AmTech Group Gentamicin Sulfate Pig Pump Oral Solution (118-ml)
Model:
V-083-2010
Product: AGRIpharm Sulfadimethoxine 12.5% Oral Solution (1-gal)
Model:
V-084-2010
Product: Farnam Double Strength D-Worm 120 Dog Dewormer (60-ml)
Model:
V-085-2010
Product: Clindamycin Hydrochloride Oral Liquid (20-ml)
Model:
V-086-2010
Product: Ivermectin Pour-On for Cattle (Various sizes)
Model:
V-087-2010
Product: Farnam D-Worm 60 Dog Dewormer (60-ml)
Model:
V-088-2010
Product: AmTech Group Liquid Spectam Scour-Halt (Various sizes)
Model:
V-089-2010
Product: IVX TiaGard (tiamulin) Liquid Concentrate (1-qt)
Model:
V-090-2010
Product: Amprolium 9.6% Oral Solution (32-oz and 1-gal)
Model:
V-091-2010
Product: Phoenix Scientific 20% Sulfaquinoxaline Sodium Solution (1-gal)
Model:
V-092-2010
Product: DVM ChlorhexiDerm Shampoo 2% (Various sizes)
Model:
V-093-2010
Product: DVM Malaseb Shampoo (Various sizes)
Model:
V-094-2010
Product: DVM Relief Creme Rinse (Various sizes)
Model:
V-095-2010
Product: DVM Maximum ChlorhexiDerm Shampoo 4% (Various sizes)
Model:
V-096-2010
Product: DVM ChlorhexiDerm Flush (4- and 12-fl oz)
Model:
V-097-2010
Product: DVM Malaseb Flush (4- and 12-fl oz)
Model:
V-098-2010
Product: DVM Malaseb Spray (8-fl oz)
Model:
V-099-2010
Product: DVM Relief Shampoo (Various sizes)
Model:
V-100-2010
Product: DVM Relief Spray (8-fl oz)
Model:
V-101-2010
Product: T8 Solution Ear Rinse (4- and 12-fl oz)
Model:
V-102-2010
Product: DVM Malaseb Concentrate (32-fl oz)
Model:
V-103-2010
Product: DVM T8 Keto Flush (4- and 12-fl oz)
Model:
V-104-2010
Product: DVM AloCetic Ear Rinse (4- and 12-fl oz)
Model:
V-105-2010
Product: DVM CortiCalm Lotion (3- and 6-fl oz)
Model:
V-106-2010
Product: DVM LymDyp Pet Dip (16-fl oz and 1-gal)
Model:
V-107-2010
Product: DVM NuSal T Shampoo (Various sizes)
Model:
V-108-2010
Product: DVM OtiCalm Ear Solution (4- and 12-fl oz)
Model:
V-109-2010
Product: DVM OtiFoam Ear Cleanser (8-fl oz)
Model:
V-110-2010
Product: DVM OtiRinse Ear Cleansing/Drying Solution (8-fl oz)
Model:
V-111-2010
Product: DVM ChlorhexiDerm Plus Scrub (1-gal)
Model:
V-112-2010
Product: DVM Maximum ChlorhexiDerm HC Shampoo (Various sizes)
Model:
V-113-2010
Product: DVM Relief HC Spray (8-fl oz)
Model:
V-114-2010
Product: DVM LymDyp Concentrate (16-fl oz and 1-gal)
Model:
V-115-2010
Product: DVM LymDyp Spray (16-fl oz)
Model:
V-116-2010
Product: DVM ChlorhexiDerm Solution 2% (1-gal)
Model:
V-117-2010
Product: DVM SulfOxyDex Shampoo (Various sizes)
Model:
V-118-2010
Product: DVM OxyDex Shampoo (Various sizes)
Model:
V-119-2010
Product: Pyrantel Pamoate Paste (18.8-g and 37.6-g syringes)
Model:
V-120-2010
Product: Ivermectin Paste 1.87% (6.08-g and 7.30-g syringes)
Model:
V-121-2010
Product: DVM KeraSolv Gel (1-oz tube)
Model:
V-122-2010
Product: DVM OxyDex Gel (1-oz tube)
Model:
V-123-2010
Product: Tetracycline Hydrochloride Soluble Powder (5- and 25-lb pails)
Model:
V-124-2010
Product: Oxytetracycline Hydrochloride Soluble Powder (6.4-oz pouches)
Model:
V-125-2010
Product: AmTech Oxytetracycline HCl Soluble Powder-343 (9.6-oz pouch)
Model:
V-126-2010
Product: Levamisole Hydrochloride Soluble Pig Wormer (20.17-g bottle)
Model:
V-127-2010
Product: Lincomycin Hydrochloride Soluble Powder (40-g pouch)
Model:
V-128-2010
Product: Phoenix Scientific Lincomycin-Spectinomycin Water Soluble Powder (2.65-oz bottle)
Model:
V-129-2010
Product: DVM EctoKyl 3X Flea and Tick Shampoo (Various sizes)
Model:
V-130-2010
Product: DVM EctoKyl CA Flea & Tick Shampoo (Various sizes)
Model:
V-131-2010
Product: Dextrose 50% Injection (500-ml vial)
Model:
V-132-2010
Product: Calcium Gluconate 23% Solution (500-ml vial)
Model:
V-133-2010
Product: Calcium-Magnesium-Phosphorus-Potassium-Dextrose Solution (500-ml vial)
Model:
V-134-2010
Product: Cal-Phos #2 Injection (500-ml vial)
Model:
V-135-2010
Product: Sterile Saline Solution 0.9% (Various sizes)
Model:
V-136-2010
Product: Sodium Iodide 20% Injection (250-ml vial)
Model:
V-137-2010
Product: Sterile Water for Injection (Various sizes)
Model:
V-138-2010
Product: Electrolyte Solution with Dextrose (500- and 1,000-ml vial)
Model:
V-139-2010
Product: Lactated Ringers Injection (1,000-ml vial)
Model:
V-140-2010
Product: Vitamin B12 1000 mcg (Various sizes)
Model:
V-141-2010
Product: Vitamin B12 3000 mcg (100- and 250-ml vial)
Model:
V-142-2010
Product: Vitamin B12 5000 mcg (100-ml vial)
Model:
V-143-2010
Product: Xylazine HCl Injection 100 mg/ml (50-ml vial)
Model:
V-144-2010
Product: Hypertonic Saline Solution 7.2% (1,000-ml vial)
Model:
V-145-2010
Product: Dexamethasone Solution 2 mg/ml (100-ml vial)
Model:
V-146-2010
Product: Iron Dextran Injection-100 (100-ml vial)
Model:
V-147-2010
Product: Gentamicin Sulfate Solution 100 mg/ml (100- and 250-ml vial)
Model:
V-148-2010
Product: Phenylbutazone 20% Injection (100-ml vial)
Model:
V-149-2010
Product: Vitamin K1 Injection 10 mg/ml (100-ml vial)
Model:
V-150-2010
Product: d-Panthenol Injection 250 mg/ml (100-ml vial)
Model:
V-151-2010
Product: Oxytetracycline Injection 200 mg/ml (Various sizes)
Model:
V-152-2010
Product: Flunixin Meglumine Injection 50 mg/ml (100- and 250-ml vial)
Model:
V-153-2010
Product: Oxytetracycline Hydrochloride Injection 100 mg/ml (500-ml vial)
Model:
V-154-2010
Product: Pfizer Norcalciphos Parenteral Solution (500-ml vial)
Model:
V-155-2010
Product: Tripelennamine Hydrochloride Injection 20 mg/ml (250- and 500-ml vial)
Model:
V-156-2010
Product: Potassium Chloride Injection Concentrate (10- and 20-ml vial)
Model:
V-157-2010
Product: Sulfadimethoxine Injection 40% (250-ml vial)
Model:
V-158-2010
Product: Ivermectin Injection for Cattle and Swine 1% (Various sizes)
Model:
V-159-2010
Product: Atropine Sulfate Injection 1/120 grain (100-ml vial)
Model:
V-160-2010
Product: Epinephrine Injection USP 1:1000 (30-ml vial)
Model:
V-161-2010
Product: Iron Dextran Injection-200 (100-ml vial)
Model:
V-162-2010
Product: AmTech SPECTAM Injectable 100 mg/ml (500-ml vial)
Model:
V-163-2010
Product: Life Science P-Bloc Injection (100-ml vial)
Model:
V-164-2010
Product: Mannitol Injection 20% (100-ml vial)
Model:
V-165-2010
Product: DVM Malaseb Pledgets (60-ct container)
Model:
V-166-2010
Product: IVX Malaseb Towelettes (12- and 60-ct packs)
Model:
V-167-2010
Product: AgriLabs Prohibit Soluble Drench Powder (1.8-oz packet)
Model:
V-168-2010

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 53786
Status: Resolved
Manufacturer: TEVA Animal Health Inc
Sold By: Butler Animal Health; Agri Laboratories; Clipper Distributing Co; Aspen Veterinary Resources; Vedco Inc; IBA Inc; Farnam Companies; Universal Cooperatives; Novopharm Limited; Pfizer Animal Health
Manufactured In: United States
Units Affected: 92 products (22,624/1,000-ml. bottles; 11,520/1,000-ml. bottles; 11,272/500-ml. bottles; 14,338/500-ml. bottles; 6,737/1-gal. and 72,030/1-pt. btls; 174,247 btls.; 3,648/4-fl. oz. btls.; 227,312/1-gal. btls.; 122,265/2-fl.-oz. btls; 1,015,133/20-ml. btls; 503,294 btls.; 121,888/60-ml. btls; 89,739 btls; 35,506/1-qt. btls; 432/32-fl. oz. and 64,499/1-gal. btls; 544/1-gal. btls; 71,808/8-fl. oz., 43,638/12-fl. oz., and 1,716/1-gal. btls; 559,761 btls; 16,257/8-fl. oz., 6,648/12-fl. oz., and 925/1-gal. btls; 142,781 btls; 154,628 btls; 107,136 btls; 32,388/8-fl. oz. btls; 196,690 btls; 58,549/8-fl oz btls; 52,321 btls; 1,613/32-fl oz btls; 606,459 btls; 44,241 btls; 11,499 btls; 13,678 btls; 62,586 btls; 276,899 btls; 46,182/8-fl. oz. btls; 186,551/8-fl oz btls; 5,271/1-gal btls; 1,266 btls; 55,775/8-fl oz btls; 21,719 btls; 15,588/16-fl. oz. btls; 9,982 units/1-gal btls; 73,482 btls; 33,476 btls; 792,418 syringes; 3,746,495 syringes; 70,490/1-oz. tubes; 22,792 units/1-oz. tubes; 132,553 pails; 108,425 pails; 15,175 pails; 23,727/20.17-g btls; 409,850 pails; 39,308/2.65-oz. btls; 46,541 btls; 38,081 btls; 1,957,516/500-ml. btls; 258,378/500-ml vials; 722,542/500-ml. vials; 343,289/500-ml vials; 632,485 vials; 124,661/250-ml vials; 735,982 vials; 347,856 vials; 201,937/1,000-ml vials; 11,376/100-ml vials; 2,820/250-ml vials; and 3,264/500-ml vials; 144 /100-ml vials and 3,432/250-ml vials; 3,888/100-ml vials; 139,375/50-ml vials; 419,749/1,000-ml vials; 340,585/100-ml vials; 305,157/100-ml vials; 424,727 vials; 69,935/100-ml. vials; 43,173/100-ml vials; 4,284/100-ml vials; 178,791 vials; 227,709 vials; 239,441/500-ml vials; 645,513/500-ml vials; 7,180/250-ml vials and 53,658/500-ml vials; 202,337/10-ml vials and 33,170/20-ml vials; 229,441/250-ml vials; 238,777 vials; 103,453/100-ml vials; 40,564/30-ml vials; 1,198,365/100-ml vials; 61,589/500-ml vials; 17,121/100-ml vials; 8,820/100-ml vials; 166,737/60-ct. containers; 13,015/60-ct. shelf packs and 161,047/12-ct. shelf packs; 7,320/1.8-oz. packets)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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 · Raw API Response