MAY 2008
PRODUCT
a) MGA200
Premix (Type A Medicated Article), each pound contains 200 mg.
Melengestrol Acetate, packaged in a white, multi-layered
paper bag containing
approximately 10 lbs. of product
with the drug name handwritten on it,
b) Lincomix 20 (lincomycin) Type A Medicated Article 20 grams/lb,
packaged in a
white, multi-layered paper bag containing
approximately 5 lbs. with the drug name
handwritten on
it,
CODE No lot
number
RECALLING FIRM/MANUFACTURER Milbank Mills Inc.,
Chillicothe, MO,
REASON The product was repackaged with
deficient labeling.
VOLUME OF PRODUCT IN COMMERCE 10 lbs.
MGA200 and 5 lbs. Lincomix
DISTRIBUTION MO
APRIL 2008
PRODUCT
a) VetTek
Hypertonic Saline Solution 7.2% Sterile-Preservative Free For Animal Use Only, packaged in 1,000-mL bottles, each 100 mL of
sterile aqueous solution contains sodium chloride 7.2 g,
RX, NDC 60270-813-20,
b) VetTek C-M-P-K Injection,Calcium-Magnesium-Phoshorus-Potassium-Dextrose Solution,
For Animal Use Only, packaged in 500 mL bottles, each 500 mL of sterile aqueous solution contains Calcium 10.8 g (as calcium
borogluconate, equivalent to calcium gluconate 23.2%,
Potassium 8.0 g (as potassium chloride), Phosphorus 2.5 g
(as sodium hypophosphite.H2O, Magnesium 1.6 g (as magnesium borogluconate), Dextrose.H2O 75.0 g, NDC 60270-026-17, RX,
CODE
a) Lot 704114F;
b) Lot
#711385F
RECALLING FIRM/MANUFACTURER IVX Animal Health
Inc., Saint Joseph, MO,
REASON Lack of sterility
assurance.
VOLUME OF PRODUCT IN COMMERCE
a) 8,256
bottles;
b) 11,256 bottles
DISTRIBUTION MO
PRODUCT
a) Silver
Moon Feeds MED-I-MIX NO 3 (SP 250) Special ASP Medicated 3934M, Type B medicated feed, containing 10 g/lb.
chlortetracycline hydrochloride, 10 g/lb. (2.2%) sulfathiazole, and 5 g/lb. penicillin (from procaine penicillin), packaged in 10-lb. bags, 5 bags/bale,
b) Silver Moon Feeds Pig Shine Medicated 3062P, For
Starting Pigs Weighing 11 to 44 Pounds, Type C medicated
feed, containing 100 g/ton chlortetracycline hydrochloride, 0.011% sulfathiazole, and 50 g/ton penicillin (from
procaine penicillin, bulk feed and packaged in 50-lb.
bags,
CODE
a) Lot
#’s: 03707, 17007, 26407, and 35407;
b) Lot #’s: 00207, 03807, 06007, 06507,
09507, 09307, 10607, 13707, 12907, 16207, 22507, 27007,
27607, 29107, 32007, and 33407
RECALLING
FIRM/MANUFACTURER Milbank Mills, Inc, Chillicothe, MO,
REASON
Incorrect bag tag used.
VOLUME
OF PRODUCT IN COMMERCE
a) 73/10 lb. bags; b) Bulk – 47,760 lbs;
bagged – 2,219/50 lb. bags
DISTRIBUTION MO, IA
MARCH 2008
PRODUCT Polydioxanone
(PDO) Monofilament Synthetic Absorbable, Sterile
Suture (Violet in Color), 0 3.5 metric NCP-1 30" (75 cm) 1/2 37mm cutting.
Product was labeled for Veterinarian Use Only. Product is distributed under the
following labels: Mono-Dox, brand; RXV ProPoly DS brand; Monovet brand; and
Vedco brand; Product code M467,
CODE Lot Number A0700810, EXP
2010-12
RECALLING FIRM/MANUFACTURER C P Medical,
Portland, OR,
REASON Package is labeled for a 37 mm 1/2
circle cutting needle, but may contain a 37 mm tapered needle.
VOLUME
OF PRODUCT IN COMMERCE 878 boxes, each containing 12
packages
DISTRIBUTION AZ, MI, MO, NE, NV, TX and
Israel
PRODUCT Dionne Foot Rot Treatment, Topical Antiseptic, containing Iodine 1%
and Chloroxylenol 0.5%, packaged in 8-fl. oz., 16-fl. oz. (1 Pint), and 32-fl.
oz. (1 Quart) containers, OTC,
CODE Lot 7E14C, Exp. May
2009
RECALLING FIRM/MANUFACTURER Qualis Group LLC, Des
Moines, IA,
REASON Iodine active
ingredient failed stability testing (low).
VOLUME OF PRODUCT IN
COMMERCE 96/8-fl. oz., 744/16-fl. oz., and 48/32-fl. oz.
containers
DISTRIBUTION IL, MO, WA, OK, NC, IA, TN, and
SD
The Hartz Mountain Corporation Recalls Vitamin Care for Cats
The Hartz Mountain Corporation is recalling a second specific lot of Hartz Vitamin Care for Cats due to concerns that bottles within the lot may have been potentially contaminated with Salmonella. Hartz recalled a specific lot code of Hartz Vitamin Care for Cats last November due to similar concerns. Both lot codes were manufactured for Hartz by UFAC (USA) Inc. in 2007, and were removed from distribution last November. However, bottles from the second lot had been shipped to customers prior to their having been removed from distribution.
The product involved is 739 bottles of Hartz Vitamin Care for Cats, lot code SZ 22771, UPC number 32700-97701. While normal testing conducted by Hartz and UFAC has not revealed the presence of Salmonella in any Hartz products, recent sampling conducted by the FDA did detect the presence of Salmonella.
Cat owners should check the lot code on their bottles, and, if the code is not visible, or if the bottle has lot code SZ 22771 or lot code SZ-16371 imprinted thereon, they should immediately discontinue use of the product and discard it in a proper manner.
Consumers can contact Hartz at 1-800-275-1414 with any questions they may have and to obtain reimbursement for purchased product.
FEBRUARY 2008
PRODUCT
a)
UDDERCARE Washing Liquid Labeled as 100% natural product in 30 ml syringes sold in cartons of 20 syringes. The 30mL syringes are
packaged 20 per carton with a single page informational
insert and 20 alcohol prep pads.
Note: above carton and
tubes were collected as part of FDA sample, 439123 to
SAN-DO lab,
b) Organic Wash packaged in 30 ml syringes
packaged in cartons of 20,
CODE
a) 19 tubes/syringes lot: J161, EXP:
06/10, and MNF: 06/07,
20-syringe carton lot: J161, EXP:
06/10, MNF: 06/07, and code: 10035;
b) This product is no longer distributed
according to the distributor but is the same
product as UDDERCARE. The lot implicated for UDDERCARE is
J161.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Durotec
Usa Co., Vancouver, WA,
Manufacturer: New Decade Investments (Pty) Ltd, Walmer,
South Africa.
REASON Uddercare product used for teat wash for
dairy cows is contaminated with bacteria.
VOLUME OF PRODUCT IN
COMMERCE 7,000 units
DISTRIBUTION WA, CA,
OR
PRODUCT
a) Wild
Kitty Cat Food – Raw All Natural Chicken with Clam Recipe, Plastic 3.5 oz. (100g) and 16 oz. (1 lb.) units packaged in plastic.
Recall # V-016-2007;
b) Wild Kitty Cat Food – Raw All Natural Duck with Clam
Recipe, Plastic 3.5 oz.
(100g) and 16 oz. (1 lb.) units
packaged in plastic. Recall # V-017-2007
CODE Uncoded
product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wild
Kitty Cat Food, Inc., Arundel, ME,
Manufacturer: Nodine,
Torrington, CT.
REASON Cat Food contaminated with
Salmonella
VOLUME OF PRODUCT IN COMMERCE 12,204/3.5 oz.
and 2,816/1 lb. units
DISTRIBUTION CT, FL, IL, MA, MD,
ME, MI, NM, NJ, NY, WA
PRODUCT Pharmacia
& Upjohn Quartermaster Suspension, penicillin-dihydrostreptomycin in oil,
each 10-mL disposable syringe contains 1,000,000 units of Procaine Penicillin G,
micronized, and 1 gram of Dihydrostreptomycin base, as Dihydrostreptomycin
Sulfate, in an extended action base, packaged 144 syringes/pail, RX, NADA
055-028,
CODE DC-1499 and
DC-1483
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Pfizer Inc., New York, NY,
Manufacturer: West Agro Inc.,
Hamilton, NY.
REASON Quarantined product at distributor that
was out of specification (high) was inadvertently distributed.
VOLUME
OF PRODUCT IN COMMERCE 772 pails DC-1499 and 240 pails
DC-1483
DISTRIBUTION IA, CO, ID, NE and
TX
PRODUCT
Ivermectin Liquid for Horses, 10 mg per mL, ANDA 200-202, RX,
packaged in 100- and 200-ml multi-dose vials under the following brand
names/labels:
1) Am Tech Group, Inc. Phoenectin, NDC 59130-680-01 (100-ml)
and 59130-680-2
(200 ml);
2) Butler Parid EQ Oral
Liquid, NDC 11695-3591-1 (100 ml) and 11695-3591-2
(200
ml);
3) Phoenix Pharmaceutical, Inc. Ivercide, NDC 57319-400-05 (100 ml) and
57319-400-
42 (200 ml);
4) VEDCO ProMectin E, NDC
50989-484-12 (100 ml) and 50989-484-34 (200 ml),
CODE 100- and 200-ml sizes: 5010014, Exp.
01/08; 5121612, Exp. 12/08; 6071103, Exp. 07/09; 6101773, Exp. 10/09; 6122017,
Exp. 12/09; 100-ml. only - 5020204, Exp. 02/08; 5050659, Exp. 05/08; 6010125,
Exp. 01/09; 6040498, Exp. 04/09; 7030412, Exp. 03/10; 200-ml. only - 5040568,
Exp. 04/08; and 7040594, Exp. 04/10
RECALLING
FIRM/MANUFACTURER IVX Animal Health Inc., Saint Joseph, MO
REASON
Precipitate forms after bottles have been
opened.
VOLUME OF PRODUCT IN COMMERCE 100-ml - 100,041
vials; 200-ml - 40,974 vials
DISTRIBUTION Nationwide
PRODUCT Monofilament Polydioxanone Synthetic Absorbable
(PDO), Sterile
Suture (Violet Color) 0 (3.5 metric) 30" (75 cm) 1/2 37 mm Taper. Products were
labeled: For Veterinarian Use Only. Product is distributed under the following
labels: goDox brand; Mono-Dox brand; WEBMAXtm; Monovet; MONOSORB and MSA brand.
Product code M340,
CODE Lot
B06055110, EXP 2010-01
RECALLING FIRM/MANUFACTURER C P
Medical, Portland, OR,
REASON Monofilament sutures incorrectly
labeled. Package is labeled with Suture Size 0 but may contain Suture Size
3/0.
VOLUME OF PRODUCT IN COMMERCE 547 boxes (each
containing 12)
DISTRIBUTION AZ, LA, MA, MI, MO, NC, OH
and TX