Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon and Washington

Wilsonville, Ore. – Oregon Compounding Centers, Inc., dba Creative Compounds, is voluntarily recalling certain unexpired human and veterinary sterile products to the consumer level due to lack of sterility assurance.

The company has not received any reports of product contamination or adverse events to date, but is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

“We are fully cooperating with health officials,” said Denise Burnham, R.Ph., owner and pharmacist. “We deeply regret the impact this voluntary recall has on our customers, but patient safety is our highest priority.”

All recalled products have a label that includes the Creative Compounds name as well as a lot number. The recalled products were made from July 1, 2014 through September 22, 2014, and distributed to health care facilities, physicians, and patients in two states, Oregon and Washington.

The recall does not pertain to any non-sterile compounded medications prepared by the pharmacy.

All unexpired lots of the following sterile compounded products are subject to the recall:

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Chrysler recalls some 2013-2014 SRT Vipers

Photo Road & Track web site.

Photo Road and Track.

Chrysler Group LLC (Chrysler) is recalling certain model year 2013-2014 SRT Viper vehicles manufactured November 28, 2012, to June 26, 2014. Due to inaccurate seat position sensors, the frontal air bags may deploy with a lower velocity than designed for the actual seat position.

In the event of a vehicle crash necessitating air bag deployment, an air bag that deploys at a lower velocity than designed may increase the risk of personal injury.

Chrysler will notify owners and dealers will install a metal shim on the detection plate to correct the seat position sensor accuracy free of charge. The recall is expected to begin October 24, 2014. Owners may contact Chrysler customer service at 1-800-853-1403. Chrysler’s number for this recall is P52.

KYMCO Recalls ATVs Due to Burn, Fire Hazards

640-1-MXU-700i-GreenKYMCO USA, of Spartanburg, S.C. is recalling certain of its ATVs because of burn and fire hazards. The recall effects approximately 540 ATVs were sold at KYMCO dealers nationwide from April 2013 to August 2014 for about $9,000.

In hot environments or high elevations, the fuel cap can fail to vent properly, causing the fuel to heat up and pressure to build up in the tank. The pressure can cause the fuel tank to rupture or the fuel to boil out of the tank onto the operator or hot engine, resulting in burns to the operator or a fire.

The recall involves model year 2013, 2014 and 2015 KYMCO MXU 700 all-terrain vehicles (ATVs) including standard, LE and Camo versions. The vehicles came in black, camouflage, gold, green, red and silver. The words KYMCO and MXU 700, MXU 700 LE or MXU 700 Camo are on the front of the hood and on each rear fender. The vehicle identification number (VIN) in the format RFBLU45U*xBxxxxxx is located on the frame behind the right front wheel. The 10th digit of the VIN indicates the model year: D = 2013, E = 2014 and F = 2015. ATVs with the last six VIN digits in the following ranges are being recalled:

Model year VIN RANGE (VINs begin with RFBLU45U*)
2013 DB120111 through DB130158
2014 EB120203 through EB130204
2015 FB120315 through FB320123

Consumers should immediately stop using the recalled ATVs and contact an authorized KYMCO dealer for a free repair. The original gas caps must be collected by the dealer to confirm the repair.

SAM Medical Products Implements Voluntary Recall of its Accessory (Axilla) Strap for the SAM Junctional Tourniquet

SAM MEDICAL PRODUCTS JUNCTIONAL TOURNIQUETSAM Medical Products announced today that it has begun notifying customers of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the Axilla application of the SAM Junctional Tourniquet (SJT). The company discovered through customer feedback and subsequent additional internal testing that a very low percentage of the clips in question failed during repetitive use in training. If this piece were to fail in actual use the operator may face a potential delay in using the SJT in the Axilla area.

The company has not received any reports of patient injuries to date related to this issue nor has it been reported to fail during actual patient use. “Despite the very low percentage of failures we have seen with this clip, we feel that it is in our customers’ best interest to proactively replace all of the straps in the field” said Sam Scheinberg, Founder and CEO of SAM Medical Products. “We understand how mission critical these devices are and stand behind the quality and reliability of all SAM products”.

SAM Medical had notified customers of the voluntary recall by letter and is arranging with its customers to rapidly replace the current axilla straps with an updated version. All other indications of the SJT (Inguinal hemorrhage and pelvic fracture) are not impacted by this modification and perform as intended. The U.S. Food and Drug Administration (FDA) and other regulatory bodies have been notified.

For more information or questions related to this notification, please contact Customer Service at 1-800-818-4726 or (503) 639-5474 or email at customerservice@sammedical.com.

The SAM Junctional Tourniquet has received 510K clearance for controlling inguinal hemorrhage, axilla hemorrhage, and pelvic fracture stabilization. Built upon the design of the SAM Pelvic Sling II (with over 250,000 patient treatments worldwide since its inception in 2003), the SJT stands alone in versatility, size and weight, as well as rapid application time to achieve hemorrhage control (less than 25 seconds in most cases). The SJT is designed to control bleeding where standard tourniquets would not be effective.

HAR Maspeth Corp recalls Jinga brand “Pan Fried Anchovies” Because of possible health risk

HAR Maspeth Corp. of Maspeth, NY, is recalling its 2 ounce and 4 ounce packages of Jinga “Pan Fried Anchovies” due to contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Although healthy persons may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The recalled Jinga “Pan Fried Anchovies” were distributed nationwide in retail stores and through mail orders. The product comes in a 2 ounce and 4 ounce, clear plastic packages marked with an expiration date of “9/28/2014” stamped on the top.

An alleged illness has been reported to date in connection with this problem.

The recall was initiated after routine sampling by The Virginia Department of Agriculture and Consumer Services Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the presence of Listeria monocytogenes.

J&B European Distribution Inc. Issues Allergy Alert For Undeclared Milk In Kupiec Rice Cakes With Dark Chocolate

J&B EUROPEAN DISTRIBUTION INC. of BROOKLYN, NY is recalling 40 cases of KUPIEC brand RICE CAKES WITH DARK CHOCOLATE, NET WT. 3.1 OZ. (90g), UPC # 5 906747 171742, because they may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

KUPIEC brand RICE CAKES WITH DARK CHOCOLATE, NET WT. 3.1 oz. (90g) were distributed to retail outlets throughout NY, NJ, and PA, and to one retail location in North Carolina. The product was shipped between 6/24/2014 and 7/23/2014.

KUPIEC brand RICE CAKES WITH DARK CHOCOLATE, NET WT. 3.1 oz., UPC # 5 906747 171742, are packed in a white oval plastic package picturing a stack of the rice cakes topped with chocolate. There are 6 rice cakes per package. The product was imported from Poland.

J&B EUROPEAN DISTRIBUTION is not aware of any confirmed illnesses to date in its distribution area; however the FDA has confirmed one such case in the Chicago, IL area.

The recall was initiated after it was discovered that product containing milk was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by an inadvertent omission on the label by the producer during the revision of the packaging process.

Consumers who have purchased KUPIEC brand RICE CAKES WITH DARK CHOCOLATE, NET WT. 3.1 oz., UPC # 5 906747 171742, are urged to return it to the place of purchase for a full refund. Consumers with questions may contact J&B EUROPEAN DISTRIBUTION at 1-718-782-3712, Monday – Friday, 8am – 4pm, ET.

Minnesota Firm Recalls Meat and Poultry Products for Possible Listeria Contamination

Buddy's Kitchen photo.

Buddy’s Kitchen photo.

WASHINGTON – There is a Class I recall for certain Buddy’s Kitchen food items. With a Class I, there, “[I]s a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.”

Buddy’s Kitchen, a Burnsville, Minn. establishment, is recalling approximately 62,488 pounds of meat and poultry products due to possible contamination with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.

Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract.

In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn.

In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems.

Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.

The meat and poultry breakfast products were produced on various dates from July 16, 2014 through Sept. 25, 2014, and then shipped to distributors, retail locations, and airlines nationwide. The following products are subject to recall:

  1. “Swiss Cheese and Mushroom Omelet with Seasonal Tid-Bit Potatoes & Turkey Buffet Sausage Link” trays with the production codes “07/16/14 9”, “08/08/14 9” and “08/27/14 9”.
  2. “Savory Scrambled Eggs with Seasoned Red Skin Potatoes and Turkey Buffet Links” with the production codes “09/19/14 9” and “09/22/14 9”.
  3. “Garden Omelet w/ Parslied Potatoes & Chicken Sausage Links” with the production codes “07/16/14 9”, “07/17/14 9”, “07/18/14 9”, “07/22/14 9”, “07/25/14 9”, “08/22/14 9”, “08/25/14 9”, “09/02/14 9”, “09/09/14 9” and “09/16/14 9”.
  4. “Fiesta Scramble Bowl with Sausage Links” with the production code “10I14 9”.
  5. “Breakfast Skillet Burrito with eggs, sausage and cheese” with the production codes “18G14 2”, “06I14 4”, “16G14 4”, “17G14 2”, “07H14 4”, “20H14 2”, “21H14 4”, “22H14 4” and “25H14 4”.

Case labels or packaging may bear the establishment number “EST. 4226” or “P-4226” inside the USDA mark of inspection.

FSIS recommends the following safety guidelines:

  1. Wash hands with warm, soapy water before and after handling raw meat and poultry for at least 20 seconds.
  2. Wash cutting boards, dishes and utensils with hot, soapy water. Immediately clean spills.
  3. Do not eat hot dogs, luncheon meats, bologna or other deli meats unless reheated until steaming hot.
  4. Do not eat refrigerated pate, meat spreads from a meat counter or smoked seafood found in the refrigerated section of the store. Foods that do not need refrigeration, like canned tuna and canned salmon, are safe to eat. Refrigerate after opening.
  5. Do not drink raw (unpasteurized) milk and do not eat foods that have unpasteurized milk in them.
  6. Do not eat salads made in the store, such as ham salad, chicken salad, egg salad, tuna salad or seafood salad.
  7. Do not eat soft cheeses, such as Feta, queso blanco, queso fresco, Brie, Camembert cheeses, blue-veined cheeses and Panela, unless it is labeled as made with pasteurized milk.
  8. Use precooked or ready-to-eat food as soon as you can. L. monocytogenes can grow in the refrigerator. The refrigerator should be 40º F or cooler and the freezer 0º F or colder Use an appliance thermometer to check the temperature of your refrigerator.

Bad Bad Boy Buggies recreational vehicle recalled due to crash hazard.

BBB_Instinct_Red_640Bad Boy Buggies of Agusta Georgia is recalling three of its off-road, four-wheeled recreational vehicles due to brake problems which could result in a crash. No incidents have yet been reported.

This recall involves gas- and electric-powered, four-wheeled recreational vehicles manufactured by Bad Boy Buggies. The models are Ambush and Ambush iS, Instinct, Recoil and Recoil iS.

The vehicles have bench seats for the driver and passenger, a cargo bed in the rear of the two-person model, and a rear-facing back seat in the four-person model. The recreational vehicles were sold in black, camouflage, green and red, and have 1¾ inch tubular steel exterior frames.

The recalled off-road vehicles have serial numbers ranging from 8004970 through 8012901. Serial numbers are printed on a plate or label on the steering column. Brand and model names are printed on the side and front panels of the vehicle. Model names included in the recall are:

Consumers should immediately stop using the recalled vehicles and contact Bad Boy Buggies or an authorized dealer for a free repair.

Arctic Cat recalls side-by-side due to fire hazard

300px-WildcatTrail_LimeArctic Cat of Thief River Falls Minnesota is recalling two of it’s side-by-sides utility vehicles after receiving 60 reports of oil leaking one one fire. The vehicles were sold at Arctic Car dealers nationwide from December 2013 to July 2013. The vehicles retailed from $11,400 to $12,400.

Consumers are advised to stop using the vehicles and contact their Arctic Cat dealer to schedule a free repair.

This recall involves all 2014 Arctic Cat Wildcat Trail and Wildcat Trail XT side-by-side utility vehicles with Vehicle Identification Numbers (VIN) 000001 through 316232. The VIN is located on the frame tube near the driver’s side front wheel. These units were sold in red, green, lime green, team arctic green and mat black. The words “Arctic Cat” and “Wildcat Trail” appear on the sides of these vehicles and on the hood.

Kidde recalls hard-wired smoke/CO2 alarms

smoke-alarm-recallWASHINGTON – Kidde United Technologies is recalling three of its hardwired smoke alarms. The recall affects 1.2 million units sold in America and about 112,000 units in Canada. The units were sold through various retailers, such as Home Depot and City Electric Supply, and on line from January 2014 through July 2014 for between $30 and $50.

This recall involves Kidde residential smoke alarm model i12010S with manufacture dates between December 18, 2013 and May 13, 2014, combination smoke/CO alarm il2010SCO with manufacture dates between December 30, 2013 and May 13, 2014, and combination smoke/CO alarm model KN-COSM-IBA with manufacture date between October 22, 2013 and May 13, 2014.

The units are hard-wired into a home’s electric power. The il2010S and il2010SCO come with sealed 10 year batteries inside. The KN-COSM-IBA model has a compartment on the front for installation of replaceable AA backup batteries.

The alarms are white, round and measure about 5 to 6 inches in diameter. Kidde is engraved on the front of the alarm. Kidde, the model number and manufacture dates are printed on a label on the back of the alarm. “Always On” is also engraved on the front of alarms with sealed 10-year batteries.

Consumers should immediately contact Kidde for a free replacement smoke or combination smoke/CO alarm. Consumers should keep using the recalled alarms until they install replacement alarms.