Stop sale/recall on Jencine 4 and Jencine 4L5 cattle vaccines
29 July 2008
Letter from Dr. Rick Sibbel, Technical Director (42Kb)
Stop/Sale Recall for Jencine 4 (Bovine Rhinotracheitis-Respiratory Syncytial Virus - Viral Diarrhea-Parainfluenza 3 Vaccine, Modified Live Virus); serials 226178 consecutively, through 226192, and Jencine 4 that are in combination with Lepto-5.
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FAQ's and Answers regarding the Jencine 4 and Jencine 4 L5 Recall
Q1. I’ve heard you had a Jencine recall. What products are involved and what’s the problem?
Answer: Jencine 4 and Jencine 4 L5. DNA evidence of a contaminant BVD has been found in certain serials of Jencine 4 and Jencine 4 L5.
Q2.Can you send me a copy of the recall letter?
Answer: Yes
Q3.How did the BVDV get into the product?
Answer: A contaminated nutrient for the growth media used in the manufacturing of the product appears to be the source of introduction.
Q4.What’s the strain and source of the BVDV?
Answer: The strain is BVDV type 2 and source is still being investigating by our research personnel. More definitive information will be forthcoming as available.
Q5.What serials are affected?
Answer: 226178 through 226192. These serial numbers can be found on the product packaging.
Q6. When was the first involved serial produced?
Answer: 226178 released October 16th, 2006 and all serials thereafter
Q7. Could this BVDV variant cause my cattle to get sick (show signs of BVDV)?
Answer: The pathogenicity of the contaminant virus is unknown at this time.
Q8. What sophisticated science is being used in the investigation of this vaccine contaminant? Answer: Polymerase chain reaction (PCR) technology is being used in conjunction with nucleic acid sequence analysis to characterize the contaminant virus. This technology can be used to characterize field viruses thought to be involved in field cases.
Q9. I got sick cattle. Could this BVDV contaminant be involved?
Answer: Technical Services is available to discuss any clinical investigations on a case by case basis.
Q10. Will cattle vaccinated with these products carry this strain of BVDV? If yes, how long?
Answer: Preliminary information indicates this type 2 BVDV virus can infect vaccinated cattle. Clinical studies are being considered to learn more about the BVDV.
Q11. Will the BVDV variant cause the vaccine to be ineffective?
Answer: Until we learn more about the clinical biology of the virus, we don’t know.
Q12. Should cattle vaccinated with either of these products be revaccinated with another similar respiratory vaccine?
Answer: Technical services will help customers determine the answer to this question.
Q13. I got sick cattle. What diagnostic tests need to be performed to see if this BVDV variant is involved?
Answer: Normal BVDV work-ups (virus isolation) with strain typing by PCR as the definitive goal. Protocols are being developed to further address this situation and will be made available when complete.
Q14. Where do I send diagnostic samples for evaluation?
Answer: Continue to use your normal veterinary diagnostic laboratory(s) for initial stages of evaluation. Further information will be provided in the protocols mentioned in the answer to Question 13.
Q15. Will Intervet/Schering-Plough Animal Health cover the costs of the diagnostic tests and any associated veterinary expenses?
Answer: Yes, we cover all reasonable diagnostic costs as part of our product complaint resolution process.
Q16. Are there any other Intervet/Schering-Plough Animal Health products affected?
Answer: No. We have evaluated the risk to other cattle vaccines and the contaminate virus has only been found in the manufacturing process for Jencine 4 and Jencine 4 L5.
Q17. Can I return my Jencine 4 and Jencine 4 L5 products and get my money back?
Answer: Yes. It will need to be returned to the point of purchase and reimbursement will be managed by that business.
Q18. Is the Lepto 5 portion of the Jencine 4 L5 product affected by this contaminant?
Answer: No.
If you have any additional questions, please contact Livestock Technical Services at 1-800-211-3573.
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