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Medium RiskFDA Vet
Pets & Animals/Pet Medications

The Medicine Shoppe Pharmacy: Various Veterinary Medications Recalled for Manufacturing Violations

Agency Publication Date: April 10, 2020
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Summary

The Medicine Shoppe Pharmacy is recalling 27 bottles of various veterinary compounded medications, including treatments like Potassium Bromide, Gabapentin, and Prednisolone, due to violations of Current Good Manufacturing Practice (cGMP) regulations. These violations indicate that the medications were not produced under standard quality and safety controls, which could compromise their safety or effectiveness for pets. Approximately 27 units total were distributed in Port Charlotte, Florida, between early and mid-2020.

Risk

Failure to follow proper manufacturing standards can result in products that are contaminated, have incorrect potencies, or lack the necessary stability to treat animal conditions effectively. No specific animal injuries have been reported, but medications produced outside of these safety standards pose a moderate risk to animal health.

What You Should Do

  1. Check your pet's medication labels for 'The Medicine Shoppe Pharmacy' at 3524b Tamiami Trl, Port Charlotte, Florida.
  2. Identify if you have any of the affected products by matching the specific lot numbers and 'Discard By' dates, such as Potassium Bromide 250 mg/mL (Lots 45042, 45223), Gabapentin 50 mg/mL (Lot 45208), or Enrofloxacin 50 mg/mL (Lot 45052).
  3. Stop administering any recalled medication to your pet immediately.
  4. Contact your veterinarian or pharmacist to discuss alternative treatments and to determine if your pet requires medical evaluation due to using these products.
  5. Return any unused portions of the recalled medication to The Medicine Shoppe Pharmacy in Port Charlotte for a refund and further instructions.
  6. For additional questions or to report adverse effects in animals, contact the FDA Center for Veterinary Medicine at 1-888-FDA-VETS.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and Healthcare Consultation

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

Affected Products

Product: Potassium Bromide 250 mg/mL Solution (100 mL)
Model:
V-0413-2020
Lot Numbers:
45042 (Discard by: 5/4/2020)
45223 (Discard by: 6/14/2020)
Product: Piroxicam 2 mg/mL Suspension (30 mL)
Model:
V-0414-2020
Lot Numbers:
45048 (Discard by: 4/4/2020)
45191 (Discard by: 5/9/2020)
Product: Enrofloxacin 50 mg/mL Suspension (20 mL)
Model:
V-0415-2020
Lot Numbers:
45052 (Discard by: 3/6/2020)
Product: Prednisolone (Tuna Base) 5 mg/mL Suspension (30 mL)
Model:
V-0416-2020
Lot Numbers:
45054 (Discard by: 4/5/2020)
Product: Lactulose 10 g/15 mL Solution (90 mL)
Model:
V-0417-2020
Lot Numbers:
45096 (Discard by: 8/12/2020)
45198 (Discard by: 9/7/2020)
Product: Methimazole 5 mg/0.1 mL Lipoderm (6 mL)
Model:
V-0418-2020
Lot Numbers:
44658 (Discard by 4/20/2020)
Product: Ursodiol 50 mg/mL Suspension (100 mL)
Model:
V-0419-2020
Lot Numbers:
45124 (Discard by 4/26/2020)
Product: Hydrocodone 5 mg/5 mL Suspension (100 mL)
Model:
V-0420-2020
Lot Numbers:
45142 (Discard by 8/29/2020)
45237 (Discard by: 8/29/2020)
Product: Potassium Bromide 150 mg/mL Solution (60 mL)
Model:
V-0421-2020
Lot Numbers:
45151 (Discard by: 5/2/2020)
Product: Prednisolone in Tuna Base 2.5 mg/mL Solution (30 mL)
Model:
V-0422-2020
Lot Numbers:
45153 (Discard by: 5/2/2020)
Product: Fluoxetine Transdermal 2.5 mg/0.1 mL Lipoderm (3 mL)
Model:
V-0423-2020
Lot Numbers:
45167 (Discard by: 9/1/2020)
Product: Phenoxybenzamine 5 mg/mL Suspension (30 mL)
Model:
V-0424-2020
Lot Numbers:
45173 (Discard by: 4/5/2020)
Product: Enalapril (Vet) 0.8 mg/mL Suspension (30 mL)
Model:
V-0425-2020
Lot Numbers:
45185 (Discard by: 4/9/2020)
Product: Methionine 500 mg/5 mL Suspension (Tuna Flavor) (150 mL)
Model:
V-0426-2020
Lot Numbers:
45193 (Discard by: 4/12/2020)
Product: Omeprazole 5 mg/mL Suspension (30 mL)
Model:
V-0427-2020
Lot Numbers:
45206 (Discard by: 6/11/2020)
Product: Gabapentin 50 mg/mL Suspension (Beef flavor) (30 mL)
Model:
V-0428-2020
Lot Numbers:
45208 (Discard by: 9/9/2020)
Product: Amlodipine 1.25 mg/0.1 mL Lipoderm (4.5 mL)
Model:
V-0429-2020
Lot Numbers:
44963 (Discard by: 4/30/2020)
Product: Gabapentin 30 mg/mL Suspension (30 mL)
Model:
V-0430-2020
Lot Numbers:
45249 (Discard by: 6/21/2020)
Product: Cisapride 2.5 mg/mL Suspension (100 mL)
Model:
V-0431-2020
Lot Numbers:
45256 (Discard by: 5/25/2020)
Product: Theophyllin-SR 55 mg Capsule (120 capsules)
Model:
V-0432-2020
Lot Numbers:
45260 (Discard by: 9/23/2020)
Product: Metronidazole 60 mg/mL Suspension (60 mL)
Model:
V-0433-2020
Lot Numbers:
45262 (Discard by: 5/26/2020)
Product: Amlodipine (Chicken Flavor) 2.5 mg/mL Suspension (60 mL)
Model:
V-0434-2020
Lot Numbers:
45264 (Discard by: 5/27/2020)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85406
Status: Resolved
Manufacturer: The Medicine Shoppe Pharmacy
Sold By: The Medicine Shoppe Pharmacy
Manufactured In: United States
Units Affected: 22 products (2 bottles; 2 bottles; 1 bottle; 2 bottles; 2 bottles; 1 bottle; 1 bottle; 2 bottles; 1 bottle; 1 bottle; 1 bottle; 1 bottle; 1 bottle; 1 bottle; 1 bottle; 1 bottle; 1 bottle; 1 bottle; 1 bottle; 1 bottle; 1 bottle; 1 bottle)
Distributed To: Florida
Agency Last Updated: April 16, 2020

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 ยท Raw API Response