Recalls

The FDA states: "Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.

A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences."

July 27, 2005 Enforcement Report:

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III
_______________________________
PRODUCT
a) Dermaxx™ (deracoxib) 25 mg tablets,
A coxib-class NSAID *For Use in Dogs Only*.
The product is packed in plastic screw top
bottles containing 30 and 90 tablets each.
Recall # V-091-5;
b) Deramaxx (deracoxib) 100 mg tablets,
A coxib-class NSAID *For Use in Dogs Only*.
The product is packed in plastic screw top
bottles containing 90 tablets. Recall # V-092-5
CODE
a) Lot numbers SPT3C001, SPT3C208, SPN3C213 and SPT3C029;
b) Lot number SPN3C166
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Animal Health US, Inc, Greensboro, NC, by telephone and fax on June 15, 2005, and follow up letter on June 28, 2005.
Manufacturer: Pfizer Pharmaceuticals Llc formally Gd Searle Llc, Caguas, PR. Firm initiated recall is ongoing.
REASON
Product does not meet the finished product assay specifications.
VOLUME OF PRODUCT IN COMMERCE
a) Unknown;
b) 4530 bottles
DISTRIBUTION
CA. GA, and HI

June 9, 2004 Enforcement Report: Metacam® (meloxicam)

Metacam Warning Letter 2/23/04