Question 1

Is Dexium (dexamethasone) Solution. Bimeda (1DEX022) and VetOne (1DEX032), NADA 200-312, 2mg/mL, packaged in 100 mL glass amber vial, Sterile. ANDA 200-312.

Each-ml. contains 2mg dexamethasone, 500 mg polyethylene glyco 400, 9 mg
benzyl alcohol, 1.8 mg methylparaben and 0.2 mg propylparaben as preservatives, 4.75% alcohol, HCI to adjust pH to approximately 4.9, water
for injection q.s.
For intravenous or Intramuscular injection.
USUAL DOSE:
Bovine- 5 to 20 mg
equine- 2.5 to 5 mg recalled?

Accepted Answer

Bimeda, Inc. is recalling approximately 18,341 vials of Dexium (dexamethasone) Solution and VetOne Dexamethasone Solution because the product may contain particles that appear to be crystals. These sterile injectable medications are used for cattle and horses to treat inflammatory conditions. Injecting a solution containing particulate matter can cause serious health complications for animals, including inflammation, tissue damage, or blood clots. If you have this product, contact your veterinarian or pharmacist for guidance and return any unused vials to the place of purchase for a refund.

Question 2

What should I do?

Accepted Answer

Check your veterinary supplies for Dexium (dexamethasone) Solution (Item# 1DEX022) or VetOne Dexamethasone Solution (Item# 1DEX032) in 100 mL glass amber vials. Identify if your product is affected by looking for lot code 4M022 on the packaging or vial label. Immediately stop using any vials from the affected lot and set them aside to ensure they are not administered to animals. Contact your veterinarian or pharmacist to discuss alternative treatments and to report if you have already used the affected product on an animal. Return any unused product to the pharmacy or distributor where it was purchased for a refund, and contact Bimeda, Inc. for further instructions. For additional questions, contact the FDA Center for Veterinary Medicine at 1-888-FDA-VETS (1-888-332-8387).

Question 3

How do I get a refund or replacement?

Accepted Answer

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

Bimeda, Inc.: Dexium and VetOne Dexamethasone Solutions Recalled for Particulate Matter

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information

Were You Affected by This Recall?