2010

WEEK ENDING MARCH 13

PRODUCT Brand of Lincomycin-Spectinomycin soluble powder, Water Soluble Powder, For use in Chickens only, Antibacterial and Antimycoplasmal. Packaged under the following 2 labels: 1. Agripharm Lincomycin S 50, Item Number 1LIN022; 2. Bimeda SpecLinx-50, Item Number 1LIN009. This packet contains: Lincomycin hydrochloride Equivalent to lincomycin 16.7 grams, Spectinomycin dihydrochloride pentahydrate, Equivalent to spectinomycin 33.3 grams Total Antibiotic Activity 50.0 grams. Net Weight: 75 g (2.65oz) ANDA 200-380. 
CODE Lot 54360025, EXP 11/10, and 54360026, EXP 2/11
RECALLING FIRM/MANUFACTURER
Bimeda, Inc., Le Sueur, MN,
REASON Bimeda, Inc. has voluntarily initiated a recall of SpecLinx-50 and AGRIpharm Lincomycin S 50, brand of Lincomycin-Spectinomycin Soluble Powder, because these lots were discovered to have high mold counts.
VOLUME OF PRODUCT IN COMMERCE 14,946 pouches
DISTRIBUTION Nationwide                              

Nature's Variety Expands Nationwide Recall to Include All Raw Frozen Chicken Diets 

Nature's Variety has expanded its  recall of Chicken Formula Raw Frozen Diets for dogs and cats to include the "Best If Used By" dates of 10/29/10 and 11/9/10 because these products may be contaminated with Salmonella. 

The recall includes the following products with a "Best If Used By" date of 10/29/10 or 11/9/10:

In an abundance of caution, Nature's Variety has also chosen to expand this voluntary recall to include all Chicken Formula and Organic Chicken Formula Raw Frozen Diets for dogs and cats with any "Best If Used By" date on or before 2/5/11. 

The products included in the expanded recall are any Chicken Formula or Organic Chicken Formula Raw Frozen Diet with a "Best If Used By" date on or before 2/5/11, including:

The "Best If Used By" date is located on the back of the package above the safe handling instructions. The affected product was distributed through retail stores and internet sales in the United States and Canada.

If you are a consumer and have purchased one of these products, please return the unopened product to your retailer for a full refund or replacement. If your package has been opened, please dispose of the raw food in a safe manner by securing it in a covered trash receptacle. Then, bring your receipt (or the empty package in a sealed bag) to your local retailer for a full refund or replacement.

Consumers with additional questions can call the Nature's Variety dedicated Customer Care line 24 hours a day, 7 days a week at 800-374-3142. For additional resources about High Pressure Pasteurization or other Nature's Variety food safety protocols, visit www.naturesvariety.com.

WEEK ENDING MARCH 6

PRODUCT Carmelyx 18% Multi Species Supplement Tub, Net Weight 125 lbs. (56.51 Kg) and Net Weight 225 lbs (102.2 Kg). CODE
All lots shipped since April 6, 2009 through October 30, 2009. Lot #s include: NOV 08 2008; JAN 09 2009; JAN 22 2009; JAN 27 2009; FEB 09 2009; FEB 13, 2009; FEB 20 2009; FEB 21 2009; MAR 09 2009; MAR 10 2009; MAR 18 2009; MAR 19 2009; MAR 20 2009; MAR 24 2009; MAR 26 2009; MAR 29 2009; APR 02 2009; APR 03 2009; APR 04 2009; APR 06 2009; APR 08 2009; APR 09 2009; APR 10 2009; APR 15 2009; APR 16 2009; APR 17 2009; APR 19 2009; APR 20 2009; APR 21 2009; APR 22 2009; APR 23 2009; APR 24 2009; APR 28 2009; APR 29 2009; APR 30 2009; MAY 01 2009; MAY 02 2009; MAY 04 2009; MAY 06 2009; MAY 07 2009; MAY 08 2009; MAY 09 2009; MAY 15 2009; MAY 18 2009; MAY 19 2009; MAY 21 2009; MAY 22 2009; MAY 26 2009; JUN 03 2009; JUN 04 2009; JUN 09 2009; JUN 11 2009; JUN 12 2009; JUN 13 2009; JUN 15 2009; JUN 18 2009; JUN 19 2009; JUN 22 2009; JUN 25 2009; JUN 29 2009; JUN 30 2009; JUL 02 2009; JUL 05 2009; Jul 06 2009; JUL 07 2009; JUL 08 2009; JUL 09 2009; JUL 10 2009; JUL 11 2009; JUL 13 2009; JUL 14 2009; JUL 15 2009; JUL 16 2009; JUL 17 2009; JUL 18 2009; JUL 21 2009; JUL 22 2009; JUL 25 2009; JUL 28 2009; JUL 29 2009; JUL 30 2009; JUL 31 2009; AUG 03 2009; AUG 08 2009; AUG 09 2009; AUG 10 2009; AUG 13 2009; AUG 14 2009; AUG 17 2009; AUG 19 2009; AUG 20 2009; AUG 21 2009; AUG 23 2009; AUG 24 2009; AUG 26 2009; AUG 28 2009; AUG 30 2009; SEP 01 2009; SEP 02 2009; SEP 04 2009; SEP 05 2009; SEP 09 2009; SEP 15 2009; and SEP 19 2009
RECALLING FIRM/MANUFACTURER
Cargill, Inc - Animal Nutrition Division, Seguin, TX,
Manufacturer: Positive Feed, Inc., Sealy, TX. 
REASON Product has the potential to contain elevated levels of copper.
VOLUME OF PRODUCT IN COMMERCE 365 tons
DISTRIBUTION TX


PRODUCT
1) Medicated dairy feed supplement, 4 custom blends, bulk. Bulk product not labeled. Consignee provided with documentation listing product name, ingredients, mixing directions, product code. Products include: 1) Vreugdenhil Close up, 2) Vanderwaal Close up, 3) RTJ Dry Cow; and 4) Meadow Park Close up. 

2) Non-Medicated dairy feed supplement, 7 custom blends, bulk. Bulk product not labeled. Products include: 1) Marmel Close up; 2) Bajema Close up; 3) Vanmiddendorp Close up; 4) Deck Close up; 5) Debruin Dry Cow; 6) Blankers Dry Cow; and 7) Dejong Close up. 
CODE
1) Code and run number not provided on any affixed label. Information provided on product sheets provided to each consignee specific to their blend. 1) Vreugdenhil Close up, Product Code 229423VC, Run 10202; 2) Vanderwaal Close up, Product Code 229423KC, Run 10234; 3) RTJ Dry Cow, Product Code 229500RD, Run 10318; 4) Meadow Park Close up, Product Code 229500ED, Run 10377;

2) Products are not labeled. Identification information provided to FDA by recalling firm: 1) Marmel Close up, Formula 229423MD, Run 10186; 2) Bajema Close, Formula 229423RU, Run 10187; 3) Vanmiddendorp Close up, Formula 229423VU, Run 10235; 4) Deck Close up Formula 229424JD, Run 10331; 5) Debruin Dry Cow, Formula 229426DD, Run 10370; 6) Blankers Dry Cow, Formula 229423BC, Run 10386; 7) Dejong Close up, Formula 229424DD, Run 10570
RECALLING FIRM/MANUFACTURER
Cargill Animal Nutrition, Ferndale, WA, 
REASON Undeclared urea - urea inadvertently added to the product.
VOLUME OF PRODUCT IN COMMERCE 29,040 lbs of medicated feed, 46,986 lbs. non-medicated feed
DISTRIBUTION WA

PRODUCT
1) AC power cords used with Bair Hugger Temperature Management Units: Models 505 & 750. Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger Blood/Fluid Warming Units: Models 245 (Human & Vet) and 247 Ranger Pressure Infusion Power Pack, Part # 90033). 

2) AC power cords used with Ranger Blood/Fluid Warming Unit, Model 245. Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger Blood/Fluid Warming Units: Models 245 (Human & Vet) and 247 Ranger Pressure Infusion Power Pack, Part # 90033). 
CODE Part and Model numbers only
RECALLING FIRM/MANUFACTURER
Arizant Inc., Eden Prairie, MN
REASON The affected power cords may crack and fail at/inside the plug. This recall is being issued in response to a small number of customer reports of melting, smoking or fire within the power cord plug. Multiple medical device manufacturers have recently reported power cord concerns to the FDA. Arizant has not received any reports of patient or clinician harm relating to this problem. However, the potential risks from this power cord failure include electric shock, delay in setup and therapy, interruption of therapy, device failure, and fires.
VOLUME OF PRODUCT IN COMMERCE 84,537 US, 7,380 OUS
DISTRIBUTION Nationwide, Germany, Granada, Italy

PRODUCT
1) Wysong Senior Canine Diet packaged in 4 lb and 8 lb bags. The bags are sold individual or in cases of 4 bags. The bags are shiny silver foil with black print and a picture of rising sun and a dog. UPC 8583504001. 

2) Wysong Maintenance Canine Diet packaged in 4 lb and 8 lb bags. The bags are sold individual or in cases of 4 bags. The bags are shiny silver foil with black print and a picture of rising sun and a dog. UPC 8583503001. 

3) Wysong Synorgon Canine Diet packaged in 4 lb and 8 lb bags. The bags are sold individual or in cases of 4 bags. The bags are shiny silver foil with black print and a picture of rising sun and a dog. UPC 8583504036. 
CODE
1) Lots 090623 and 090811;
2) Lots 090617, 090624, 090706, 090720, 090817;
3) Lot 090629
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wysong Medical Corp., Midland, MI, 
Manufacturer: Nutrition First Processing (NFP), Lake Mills, WI. REASON The firm received complaints of mold in dog food products.
VOLUME OF PRODUCT IN COMMERCE 363, 328
DISTRIBUTION Nationwide and Canada, Hong Kong and Singapore

WEEK ENDING FEBRUARY 27

PRODUCT
1) V6400 Invasive Pressure Monitor uses WW3005 power cord. Electri-Cord. 
2) V9200 Advisor Vital Signs Monitor utilizes the power cord WW3005. 
3) V8400 Capnocheck Capnometer utilizes the power cord 8404 for its battery charger. 
CODE
1) Power cord # WW3005;
2) Power cord # WW3005;
3) Power cord # 8404
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI, 
REASON Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are equipped with a plug that has prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug. The FDA has reported that two medical device manufactures have reported incidents of sparking, charring, and fires from the affected power cords used with their devices. Smiths medical has received no reports of incidents regarding the use of the affected Electric-Cord power cords with their devices.
VOLUME OF PRODUCT IN COMMERCE
1358 cords for all devices (1032 US, 326 OUS) (871 Human, 487 Vet), (Cord # 8404 5 Vet & 325 Human), (Cord # WW3005 482 Vet & 546 Human)
DISTRIBUTION Nationwide, Canada, and Greece

WEEK ENDING FEBRUARY 13

Nature’s Variety Issues  Recall On Raw Frozen Chicken Diets With A "Best If Used By" Date Of 11/10/10 

Nature’s Variety is recalling their Chicken Formula Raw Frozen Diet for dogs and cats with a "Best If Used By" date of 11/10/10 because these products may be contaminated with Salmonella.  The only products affected are limited to chicken medallions, patties, and chubs with a "Best If Used By" date of 11/10/10.  No other Nature’s Variety products are affected.

The affected products are limited to the Nature’s Variety Chicken Formula Raw Frozen Diet packaged in the following forms:

The “Best If Used By” date is located on the back of the package above the safe handling instructions.  The affected product was distributed through retail stores and internet sales in the United States, and in limited distribution in Canada.

Consumers with additional questions can call our dedicated Customer Care line 24 hours a day,
7 days a week at 800-374-3142.  Or, consumers can email Nature’s Variety directly by visiting naturesvariety.com.

WEEK ENDING FEBRUARY 6

PRODUCT
1) Scour-Ease plus Concentrate, Type B Medicated Feed. A calf supplement to be mixed with dry non-medicated milk replacer powder to make a complete medicated Type C milk replacer ration for dairy and beef replacement calves. Medicated with the highest approved levels of Neomycin and Oxytetracycline. Active Drug Ingredients: Neomycin Sulfate ...10g/lb.; Oxytetracycline (from Oxytetracycline Dihydrate)...10g/lb., equivalent to Oxytetracycline Hydrochloride. Packaged in 2 different sized packages: 1) Net Wt 40 lb. (18.14kg), UPC 95668-93914; 2) Net Wt 5.55 lb. (2.52 kg), UPC 95668-94256. 

2) Sav-A-Caf Scours & Pneumonia Treatment, Medicated Calf Milk Replacer. Scours & Pneumonia Treatment is a nutritionally complete medicated milk replacer to be fed to pre-weaned herd replacement calves continuously for 7 to 14 days in place of normal calf milk replacer. Active Drug Ingredients: Neomycin Sulfate...1.25 g/lb., Oxytetracycline...1.25 g/lb. (from Oxytetracycline Dihydrate) equivalent to Oxytetracycline Hydrochloride. Net Weight 6 lbs., (2.72 kg). UPC 16368-53028.  

3) SROC 20-20 AM NT 1600 Medicated. Milk Replacer to be fed to heard replacement calves. Active Drug Ingredient(s): Neomycin Base (from Neomycin Sulfate). 1600g/ton; Oxytetracycline.....1600g/ton. Net Weight 50 lb., (22.68 kg).
CODE
1) 00-9391 ScourEase+ AH919AZ 00-9391 ScourEase+ AH920CZ;
2) 01-7530 Scr & Pneum Trt AJ923CZ, AK913AZ, AM907AZ, AM908AZ;
3) 01-2060 SROC AG927
RECALLING FIRM/MANUFACTURER
Milk Products, LLC., Chilton, WI,
REASON
This recall has been initiated due to the use of Type A medication past its expiration date.
VOLUME OF PRODUCT IN COMMERCE 13, 847 lbs.
DISTRIBUTION AL, AR, IA, ID, KS, KY, MN, MO, NE, PA, TX, WI

PRODUCT Herman Prefresh Complete Pel 2 tons. Order number: 456285 02, Product number: 324TH, Delivery date: 11/18/2009. 
CODE No lot or serial numbers
RECALLING FIRM/MANUFACTURER
Kalmbach Feeds Inc., Upper Sandusky, OH, 
REASON
The recalling firm mistakenly shipped a single load of medicated swine feed containing carbadox to a dairy farm and labeled the feed as the complete dairy feed which was to have been delivered.
VOLUME OF PRODUCT IN COMMERCE 4,060 lbs.
DISTRIBUTION OH

WEEK ENDING JANUARY 23

PRODUCT
Purina Game Bird Flight Conditioner, Product code 5435, packaged in 50-lb. bags.
CODE Lot code 9SEP24LNC1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Land O Lakes Purina LLC, Shoreview, MN,
Manufacturer: Land O'Lakes Purina Feed LLC, Lincoln, NB.
REASON Feed contains plastic pieces.
VOLUME OF PRODUCT IN COMMERCE
98/50-lb. bags
DISTRIBUTION NE