Question 1

Is INDIVIDUAL CONTAINER:

Bimeda, Sustain III¿ Calf Bolus, Antibacterial Sulfamethazine, Sustained Release Calf Bolus (72hrs) , NADA120-615, Manufactured by Bimeda, Inc. Le Sueur, MN 56058, Product No. 1SUS032 8SUS019-1004, Net contents 25 Boluses, Each Bolus contains: Sulfamethazine (Formulated in a sustained released  base). 123.8 grains (8.02 grams).

Intended for oral administration  to ruminating replacement calves  (calves over (1 ) month old that are not on a an all-milk diet).

OUTER  recalled?

Accepted Answer

Bimeda, Inc. is recalling 3,760 units of Sustain III and Supra III Calf Boluses used to treat bacterial infections in calves. The recall was initiated because the medication failed stability testing, meaning the boluses dissolved faster than they were supposed to. This defect could result in the medication being released into the animal's system too quickly, potentially affecting the drug's safety and effectiveness over its intended 72-hour treatment period. These products were distributed in several states including Wisconsin, Missouri, Iowa, Minnesota, Kansas, Kentucky, Nebraska, and Texas.

Question 2

What should I do?

Accepted Answer

Check your supply for Sustain III Calf Bolus (25 or 50 count jars) or Supra III Calf Bolus (25 count jars) with Lot Number I3330221 and an expiration date of 03/13. Verify if your product matches the specific identification numbers: Product No. 1SUS032 (25 count), 1SUS033 (50 count), or 1SUS017 (Agripharm brand). Immediately stop using any boluses from the affected lot for treatment of calves. Contact your veterinarian, healthcare provider, or pharmacist for guidance regarding calves that have already been treated with this lot. Return any unused product to the place of purchase for a refund and contact Bimeda, Inc. for further return instructions. For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

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 for a refund

Bimeda, Inc.: Sustain III and Supra III Calf Boluses Recalled for Dissolution Failure

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information

Were You Affected by This Recall?