Question 1

Is GentaVed Topical Spray.  For Animal Use Only. ANADA 200-416. Each mL contains: gentamicin sulfate, USP equivalent to 0.57 mg gentamicin base, betamethasone valerate, USP equivalent to 0.284 mg betamethasone.  12-60 mL bottles/carton, Sparhawk Laboratories, Inc., Lenexa, KS 66215-3591. recalled?

Accepted Answer

Approximately 9,250 cartons of GentaVed Topical Spray (gentamicin sulfate and betamethasone valerate) for animal use are being recalled. One of the active ingredients, betamethasone valerate, was found to be below the required potency specifications during stability testing. This reduction in the drug's concentration may result in the medication being less effective than intended for treating animals. Consumers should review their supply for the affected lot number 140566.

Question 2

What should I do?

Accepted Answer

Check your animal's medication for GentaVed Topical Spray in 60 mL bottles, which are sold in cartons of 12. Locate the lot number on the packaging; this recall specifically affects Lot 140566 with an expiration date of 10/2016. If you identify an affected product, contact your veterinarian or pharmacist for guidance on alternative treatments and to report the use of the sub-potent medication. Return any remaining unused product to the place of purchase for a refund and contact Sparhawk Laboratories Inc at (913) 888-7500 for further instructions. For additional questions or to report adverse events, contact the FDA Center for Veterinary Medicine at 1-240-402-7002.

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

Sparhawk Laboratories Inc: GentaVed Topical Spray Recalled Due to Potency Below Specification

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information

Were You Affected by This Recall?