POISONOUS POWDER


Huvepharma, Inc. Issues Voluntary Nationwide Recall of Duramycin-10 Due
to Stability Failure

Huvepharma, Inc., which recently acquired the Longmont Colorado manufacturing
facility including the respective FDA registration associated with this
recall, is voluntarily recalling 1 lot of Duramycin-10 Soluble Powder,
distributed by Durvet, to the consumer level. The product had a stability
failure at the 48 month time point. Risk Statement: The product does not
have the potential to result in a health risk to any animals that are
indicated for use.

To date, Huvepharma, Inc., Durvet, and the previous FDA registration for
this product owner, have not received any reports of adverse events related
to this recall.

Duramycin-10 is indicated in Calves – for the control and treatment of
bacterial enteritis (scours) caused by
Escherichia coli and bacterial pneumonia associated with
Pasteurella species,
Actinobacillus pleuropneumoniae, and
Klebsiella species susceptible to tetracycline hydrochloride. Chickens
for the control of chronic respiratory disease (CRD air sac disease) caused by
Mycoplasma gallisepticum and
E. coli and for the control of infectious synovitis caused by
M. synoviae susceptible to tetracycline hydrochloride. Turkeys – for the control of
infectious synovitis caused by
M. synoviae; and for the control bluecomb (transmissible enteritis, corona viral enteritis)
complicated by organisms sensitive to tetracycline hydrochloride. Swine
– for the control and treatment of bacterial enteritis (scours) caused by
Escherichia coli and bacterial pneumonia associated with
Pasteurella species,
Actinobacillus pleuropneumoniae, and
Klebsiella species susceptible to tetracycline hydrochloride and is packaged in 6.4
oz. packet, with the NDC code 23676 0904. The affected Duramycin-10 lot is TSH20002 with the expiration date April
of 2017. The product can be identified by the 6.4 oz. packet baring Duramyin-10
in red font and the yellow boxed information describing the product. Duramycin-10
was distributed by Durvet nationwide to wholesale distributors and then
further to the retail and customer levels.

Huvepharma, Inc. has notified the distributors of Durvet that purchased/sold
Duramycin 10 lot number TSH20002 by letter and telephone and is arranging
for return/reimbursement of all recalled product that may be remaining
in the market place. Distributors/retailers/consumers that have Duramycin-10
which is being recalled should stop using the product and/or discard any
product baring Lot number TSH20002. Consumers with questions regarding
this recall of Duramycin-10 and/or wishing to return any unused and unopened
packages should or contact Huvepharma, Inc. at 770-486-7212 or email at
customerserviceusa@huvepharma.us Monday through Friday from 8 AM – 5 PM EST. Consumers should contact
their veterinarian if they have experienced any problems in indicated
animals that may be related to taking or using this drug product.

  • Adverse events involving animals can be reported to the FDA on Form FDA 1932a.

This recall is being conducted with the knowledge of the U.S. Food and
Drug Administration.

###

0 comments on “POISONOUS POWDER

Leave a Reply

Your email address will not be published. Required fields are marked *