Memorials/Survivors

FDA Enforcement Report 7/21/04

PRODUCT
a) Fort Dodge Amiglyde-V Injection, Amikacin Sulfate,
Veterinary Injection, Equivalent to 50 mg. Amikacin
per mL, packaged in 50-ml. vials, 48 vials per case,
RX, NADA 127-892, NDC 0856-2326-20. Recall # V-153-4;
b) Fort Dodge Cal-Dextro No. 2 Sterile Solution,
packaged in 500-ml. bottles (12 per case), each mL
contains 16.84 mg. (8.42 g/500mL) calcium (as gluconate
salt), 9.8 mg. (4.9 g/500 mL) phosphorus, 3.84 mg.
(1.92 g/500 mL) magnesium, and 165 mg. (82.5 g/500 ml)
dextrose, RX, NDC #0856-0263-01. Recall # V-154-4;
c) Fort Dodge Cal Dextro Special Sterile Solution, packaged
in 500-mL bottles (12 per case), each mL contains 22 mg.
(11 g/500/mL) calcium (as glucontate salt), 1.022 mg.
(511 mg/500 mL) phosphorus, 0.402 mg. (201 mg/500 mL)
magnesium, and 150 mg. (75 g/500 mL) dextrose, RX,
NDC 0856-0271-01. Recall # V-155-4;
d) Fort Dodge Factrel, Gonadorelin Hydrochloride, 50 mcg/mL
Sterile Solution, packaged in 20 mL and 50 mL multidose
vials (24 per case), RX, NADA 139-237, NDC 0856-4311-02.
The product is also distributed to Canada under the
Ayerst Factrel label. Recall # V-156-4;
e) Fort Dodge Flucort Flumethasone Solution, Sterile, each
mL contains 0.5 mg. flumethasone, packaged in 100-mL
multidose vials (72 per case), RX, NADA 030-414,
NDC 0856-0820-20. The product is also distributed to
Canada under the Ayerst Flucort Flumethasone Injection
Label. Recall # V-157-4;
f) Ketamine Hydrochloride Injection, USP, packaged under
the Fort Dodge Vetalar and Fort Dodge Ketaset labels,
100 mg/mL, packaged in 10-mL vials (144 vials per case),
RX, NADA 045-290, NDC 0856-2012-01. The product is also
distributed to Canada under the Ayerst Ketaset label.
Recall # V-158-4;
g) Fort Dodge ProHeart 6 (moxidectin) Sustained Release
Injectable for Dogs, packaged in 5-packs (20/5-packs per
case) and 10-packs (10/10 packs per case), RX, NADA 141-
189, NDC 0856-3670-25 (5-pack), NDC 0856-3670-20
(10-pack). Foreign distribution is made to Canada under
the Ayerst ProHeart 6 label, and to Italy under the Fort
Dodge Guardian SR label. Recall # V-159-4;
h) Fort Dodge PromAce Injectable, Acepromazine Maleate
Injection, USP, equivalent to 10 mg/mL Acepromazine
Maleate, USP, packaged in 50-mL multiple dose vials
(24 per case), RX, NADA 015-030, NDC 0856-3020-01.
The product is also distributed under the following
foreign label for Canadian distribution: Ayerst Atravet
10 mg. Injectable. Recall # V-160-4;
i) Fort Dodge Torbugesic Butorphanol Tartrate Veterinary
Injection containing 10 mg. butophanol base per mL as
butorphanol tartrate, USP, packaged in 10-ml and 50-ml.
vials (24/10-ml. per case and 48/50-ml per case), RX,
NADA 135-780, NDC 0856-2033-20. Foreign distribution is
made to: (1) Canada under the Wyeth Torbugesic label;
(2) United Kingdom under the Fort Dodge Torbugesic
Injection label. (3) Denmark under the Fort Dodge
Torbugesic Vet label. Recall # V-161-4.
CODE
a) Lot 410206;
b) Lots 263952, 263953, 263954,263955, 263956, 263957,
263958,263959, and 263960;
c) Lot 271749;
d) Lots 431334 and 431336 (50­mL only);
e) Lots 005529, 005230, and 005231;
f) Ketaset - Lots 440641, 440642, 440643, 440644, 440645,
440646, and 440647; Vetalar - Lot 440642;
g) Lots 367162220, 367162221, 367164223, and 367164224;
h) Lots 020118 and 020119;
i) Lots 454416, 454417 (10-mL only), and 454418.
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories Inc, Fort Dodge, IA, by e-mail and letters dated May 13, 2004. FDA initiated recall is ongoing.
REASON
GMP deviations cited during an inspection cause the sterility of the products to be questionable.
VOLUME OF PRODUCT IN COMMERCE
443,096 vials.
DISTRIBUTION
Nationwide and Internationally.

May 13, 2004

Tracking No. <<TrackingNo>>

<<Company>>
<<Address1>>
<<Address2>>
<<CITY>>, <<STATE>> <<PostalCode>>

Dear Customer:

Fort Dodge Animal Health is initiating a voluntary recall of the following lots of sterile pharmaceutical products:

The voluntary recall is a precautionary measure as a result of an FDA inspection which revealed the product to be adulterated within the meaning of the Food, Drug, and Cosmetic Act. The cGMP deviations cited cause the sterility of the products to be questionable, although there are no out-of-specificatioin results associated with the lots of product being recalled.

These above listed products were aseptically filled between August 29, 2003 and January 12, 2004 and distributed by Fort Dodge Animal Health from October 2003 to April 2004. If you have distributed these products to another wholesale or retail account, please provide this letter and Recall Reply Card to your account. If you have sold this product only to consumers (end users), no further notification is necessary to the consumer (end user) level. Only lots listed above are include in this recall.

Directions for Product Recall and Return:

1. Examine your stock immediately to determine if you have any of the above listed product lot numbers. If so, discontinue sales of these lots and place the inventory in a secure location.

2. Determine the quantity of the above listed lot numbers in your possession and record on the enclosed Recall Reply Card. Please inidicate on the Recall Reply Card if you have sold any of the above listed lot numbers to another wholesale or retail account and forwarded the recall information to those accounts. Please return the Recall Reply Card separately; do not mail it with the returned product.

3. Please contact a Customer Service Representative at 800-677-3728 to arrange return shipment to Fort Dodge Animal Health. Customer Service can answer any questions you may have regarding the return procedures.

We will issue your choice of replacement product or credit as soon as your return is received.

This recall is being made with the knowledge of the United States Food and Drug Administration. We appreciate your assistance and apologize for any inconvenience.

Sincerely,

Michael Mlodzik
Associate Director, Pharmaceutical Regulatory Affairs