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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Elanco Animal Health Issues Recall of Lot Number 43650A of Micotil 300 (tilmicosin injection)

Contact:
Dennis L. Erpelding
317-276-2721

FOR IMMEDIATE RELEASE -- Greenfield, IN -- March 14, 2005 -- Elanco Animal Health, Greenfield, IN initiated a recall of Lot Number 43650A of Micotil 300 (tilmicosin Injection), 250 ml vial. Micotil is a macrolide antibiotic used for the treatment of respiratory infections in cattle and sheep. The lot of Micotil was distributed without the Client Information Sheet included. The remainder of the product labeling (label, package insert) was correctly placed on the product; and these items do contain the same information. There are no other product defects associated with this lot.

As the Client Information Sheet was not included, there is a risk that individuals utilizing the product might be less apt to fully read all the information on the human safety risks associated with exposure when giving the product to cattle or sheep. To date there have been no reported injuries associated with the distribution of this lot.

Elanco initiated a voluntary recall of this lot on January 26, 2005. This recall has been recently classified as a Class I recall. Since the initiation of the recall, over 97% of the product has been returned or confirmed as having already been used, and fewer than 130 vials from this lot remain in the market. Elanco first notified its channel partners (distributors) regarding this recall on January 26, 2005.

Anyone who has a vial of only this specific lot number, 43650A, is requested to return it to the veterinarian or distributor from which they purchased the product to receive a replacement vial. For questions pertaining to the recall process, call Elanco Customer Service at 1-800-782-897, option 1.

Micotil® is a trademark for Elanco’s brand of tilmicosin injection.

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