Alert!

FAQs — Nuflor® (Florfenicol) Injectable Solution — May 2006

1. What is Nuflor Injectable Solution and what is it used for?

Nuflor Injectable Solution is an antibiotic used for treating Bovine Respiratory Disease and Footrot in cattle. It is the market leading antibiotic sold by Intervet/Schering-Plough Animal Health.

2. How do I know if my Nuflor is safe and authentic?

The most common evidence of tampering, counterfeiting, adulteration, or fraud has been the following:

Color of the rubber stopper. Genuine Nuflor Injectable Solution has a grey stopper, but the color of the stopper in counterfeit product varies (one example was red.)
Genuine Nuflor
Counterfeit
Evidence of aluminum seal tampering. Lack of a center pull-off tab or dented, scratched, missing or abnormal aluminum seals are all associated with counterfeit product.
Bottles. Counterfeit 100 mL bottles are not packaged in an approved individual carton, unlike genuine 100 mL product.
Genuine Nuflor
Counterfeit
Genuine Nuflor
Genuine 250 mL and 500 mL bottles come without a carton, but may be sold in a case of 6 with one bottle in a plastic sleeve.
Spacing system. The custom-made bottle spacing system is missing in the counterfeit 250 mL and 500 mL cases.
Lot numbers. The counterfeit product may not have lot numbers or valid expiration dating on product label.
Conflicting lot numbers. For the counterfeit product, the case lot numbers do not match the lot numbers on individual bottles within a case, or there are different lot numbers on each bottle within a single case.
Improper fill level. Genuine Nuflor Injectable Solution will be filled to a level slightly above the bottle reference mark.
Genuine Nuflor
Counterfeit
Flip-off cap. Genuine Nuflor Injectable Solution in 250 mL and 500 mL bottles has a blue flip-off cap, with a 12-point attachment to the aluminum seal. On counterfeit bottles this flip-off cap attachment did not have 12 points.
Security tape. Outside security tape on box has been opened on counterfeit product.
Genuine Nuflor
Worn label. Outside of bottle is sticky or has a worn label on counterfeit product.
Product color. The color of Nuflor Injectable solution should match the age of the product. The newer the product, the clearer the color; as the product approaches expiration date it becomes more straw colored or golden in appearance. This change in color does not affect safety or efficacy and is absent or reduced in the counterfeit product.

3. What do I do if I suspect my Nuflor is counterfeit?

Check for the most common evidence of fraud list above and if any is suspected, please call our Toll Free Technical Services number at 800-211-3573. One of our Technical Services Veterinarians will be available to assist you. If possible, photograph the suspect product.

4. What do I do if I suspect that I have been sold counterfeit product in place of Nuflor Injectable Solution?

Check for the most common evidence of fraud listed above, and if any evidence of fraud is suspected or you are not sure, please call our Technical Services number at 800-211-3573. (This number is toll free.) One of our Technical Services Veterinarians will be available to assist you. If possible, take a photograph of the suspect product.

5. What would happen if someone used counterfeit product?

Use of counterfeit product in instead of Nuflor Injectable Solution has been associated with the lack of expected efficacy due to the lack of active ingredient (Florfenicol). Since we do not know exactly what may be in a counterfeit product, other adverse effects may be possible, including the risk of violative residues from unknown excipients.

6. What do I do if I have an adverse event to report?

As with any adverse event, please contact our Technical Services Veterinarian at 800-211-3573 for assistance.

7. What is Intervet/Schering-Plough Animal Health doing to ensure the quality and integrity of Nuflor Injectable Solution?

We have fully supported, and will continue to support, the investigation being conducted by the FDA. Additionally, we have undertaken an extensive education program with our distributors and veterinarians on the safety features to look for to ensure that the Nuflor Injectable Solution you purchase is genuine.

8. Where can I go to purchase Nuflor Injectable Solution that is authentic and genuine?

We have alerted all of our authorized distributors and licensed veterinarians and provided them with a list of the signs to look for to identify tampered, counterfeit, adulterated or fraudulent product. You should continue to work with your trusted suppliers of animal health products while utilizing the safety features built into the packaging of Nuflor Injectable Solution.

9. If I bought Nuflor Injectable Solution from one of these companies and suspect that I was sold counterfeit product in its place, who do I need to contact?

If you suspect that you have purchased counterfeit product instead of Nuflor Injectable Solution, you should check for the most common evidence of fraud listed above, and if any evidence of fraud is suspected or you are not sure, call our Technical Services Staff at 800-211-3573.

10. Where was this counterfeit product sold?

We are not entirely sure how widespread the sale of counterfeit product has been. The only reported adverse events or confiscated product has been in Idaho, Washington and California.

11. Will SPAH replace any counterfeit product?

If further investigation shows that counterfeit product were purchased in good faith, Intervet/Schering-Plough Animal Health will attempt to reach a mutually acceptable resolution that may involve replacing the product with genuine Nuflor Injectable Solution.

12. Are there any other products that I should be concerned with?

At this time, we are not aware of any other Intervet/Schering-Plough Animal Health products that may have been tampered with.

13. How much does Nuflor Injectable Solution cost?

Price is set by distributors and veterinarians in a local area. Counterfeit product was often heavily discounted, and you should continue to work with your trusted suppliers of animal health products while utilizing the safety features built into the packaging of Nuflor Injectable Solution.

14. Who do we go to if the question/issue is outside of this Q&A?

If you receive or have a question that is outside of this Q&A, you need to direct the question to Technical Services at 800-211-3573.