Tag Archives: FDA

Abbott’s Compounding Pharmacy Issues Voluntary Recall of All Lots of Unexpired Sterile Human and Animal Compounded Products Due to Lack of Sterility Assurance

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Abbott’s Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California.

All recalled products have a label that includes the Abbott’s Compounding Pharmacy name and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date. This recall impacts all sterile products distributed between 01/01/2015 and 01/14/2016.

The recall was issued after a series of onsite inspections by the FDA. Out of an abundance of caution, Abbott’s Compounding Pharmacy is voluntarily recalling all sterile compounded products within expiry. If there is microbial contamination in products intended to be sterile, patients are at risk for serious and potentially life-threatening infections.

To date, Abbott’s Compounding Pharmacy has not received any reports of any adverse effects or injuries, and the recalled products were distributed exclusively within the state of California directly from its Berkeley, California pharmacy location.

Customers that have recalled product should immediately stop using it and contact the pharmacy to arrange for the return of unused product. Customers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products.

Customers with questions regarding this recall can contact Abbott’s Compounding Pharmacy by phone Monday thru Friday, 9:00am to 5:00pm at (510) 548-8777, or email its media representative.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  1. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  2. Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
  3. For reporting animal adverse drug events: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

Abbott’s Compounding Pharmacy deeply regrets any disruption that this voluntary recall and temporary suspension of Sterile compounding services have on its Customers, but notes that safety and quality are its primary concerns.

Blendtech Issues Allergy Alert on Undeclared Milk Allergen in Uncle Buck’s Fish Batter Mix – Original

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ucm482079BlendTech Inc of Wichita, KS, is voluntarily recalling one lot of Uncle Buck’s Fish Batter Mix – Original due to the presence of an undeclared milk ingredient. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled Batter Mix was distributed in Bass Pro Shops stores nationwide and through mail order.

The affected product is packaged in a 22 ounce, yellow plastic bottle with black cap, UPC 9222972528, and marked with lot #09241505 on the bottom of the bottle.

No illnesses have been reported to date in connection with this problem.

The recall was initiated after BlendTech discovered product containing milk was distributed in packaging that did not reveal the presence of milk.

Consumers who have purchased the affected product are urged to discard it. Consumers who would like replacement or have questions may contact the company at 1-844-265-7354 or at 1-316-941-9660, Monday – Friday 8:00AM to 4:30PM CST.

Mars Chocolate recalls DOVE® Chocolate Assortment Snowflakes

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Dove-3Mars Chocolate North America Issues Allergy Alert Voluntary Recall on Undeclared Peanuts, Wheat and Egg Ingredient for DOVE® Chocolate Assortment Snowflakes, 24.0 oz. Bag, Sold Only at One Major Retailer with Stores Across the U.S.

Today, Mars Chocolate North America announced a voluntary recall of its DOVE® Chocolate Assortment Snowflakes, 24.0 oz. bag – this is a seasonal item only sold at one major retailer with stores across the U.S.

Item# 10139802 – UPC# 400050521
LOT CODE: 537CG4PA30, 537DG4PA30, 538AG4PA30, 538AM4PA30, 541AG4PA20, 542EM4PA20

This item is a purple 24 oz. bag clearly marked with DOVE® Chocolate Assortment Snowflakes branding on the front of packaging. The code dates and UPC code are located on the back of the packaging on the lower right side.

Approximately 6,700 cases of this item may contain some SNICKERS®, MILKY WAY® and TWIX® pieces that contain peanuts, wheat and/or eggs, but these ingredients are not listed on the outer package ingredient label. People who have allergies to peanuts, wheat and/or eggs have the risk of serious or life-threatening allergic reaction if they consume these products. No adverse reactions have been reported to date.

This item was shipped and distributed to only one retailer and sold at retail food stores starting September 19, 2015 through December 1, 2015 to the following locations: AZ, GA, MA, MS, OH, VA, CA, IA, MD, NH, OK, VT, CO, IL, ME, NJ, OR, WA, CT, IN, MI, NM, PA, WI, DE, KS, MN, NV, RI, WY, FL, KY, MO, NY and TX.

The issue was identified after a consumer notified Mars Chocolate North America of finding a SNICKERS® piece in this Dove Chocolate Assortment Snowflakes, 24.0 oz. bag.

Mars Chocolate is working with the impacted retailer to ensure that the recalled product is removed from sale. In the event that consumers believe they have purchased this item and have allergy concerns, they should return this product to the store where they purchased it for a full refund. Consumers with questions or concerns may call our toll-free number at 1-800-551-0907.

SmartLipo365 Issues Voluntary Nationwide Recall of Smart Lipo

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Dallas, TX, SmartLipo365 is voluntarily recalling 122 lots of Smart Lipo (800, 900, 950 mg) capsules, to the consumer level. FDA received samples of 800 and 900mg capsules of Smart Lipo and the lab results found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

Smart Lipo is marketed as a dietary supplement and is packaged in bottles of 30 capsules, with 22 bottles of 800mg, 77 bottles of 900mg, and 23 bottles of 950mg.The affected Smart Lipo products include the following expiration dates: 800mg capsules – 9/15/2017, 900mg capsules – 7/30/2017, 950mg capsules – 7/30/2017 & 7/30/2018. Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet, SmartLipo365.com.

SmartLipo365 is notifying its distributors and customers by e-mail and letter and will not continue the distribution of Smart Lipo. Consumers, distributors, retailers that have Smart Lipo which is being recalled should stop using the recalled product and asked to please dispose it.

Consumers with questions regarding this recall can contact SmartLipo365 by 1-(800)-547-6365 or info@smartlipo365.com on Monday through Friday from 10 A.M. to 5 P.M. (Central time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

FDA Orders Recall under Consent Decree for all Custom Ultrasonics Automated Endoscope Reprocessors

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The U.S. Food and Drug Administration today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm’s continued violations of federal law and a consent decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission. The FDA ordered this recall under the terms of the consent decree. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.

These actions are part of the FDA’s commitment to patient safety and ongoing efforts to minimize the risk of patient infections associated with reprocessed endoscopes, including duodenoscopes and scope accessories. The FDA has been working with federal partners, manufacturers and other stakeholders to better understand the critical factors contributing to bacterial infections associated with duodenoscopes and how to best mitigate them.

An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the United States. The FDA’s recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9. Within seven business days after receiving the FDA’s recall order, Custom Ultrasonics must provide a written recall proposal to the FDA.

“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The FDA’s recall order stemmed from the company’s continued violations of federal law and the consent decree and is necessary to protect the public health.”

AERs are Class II medical devices that require 510(k) clearance and are used to wash and high-level disinfect endoscopes to decontaminate them between uses. AERs are designed to expose outside surfaces as well as interior channels of endoscopes to chemical solutions in order to kill microorganisms and prevent the spread of infection from these reusable medical devices. An endoscope must be thoroughly cleaned to remove any visible debris prior to placing it in an AER, which includes manually scrubbing the elevator mechanism and the recesses surrounding the elevator mechanism.
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SpaghettiOs Original 14.2oz Cans Recalled Due to Potential Choking Hazard

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640-472515Campbell Soup Company (NYSE:CPB) is voluntarily recalling 14.2 ounce cans of SpaghettiOs Original due to a potential choking hazard posed by pieces of red plastic found in a small number of cans. This plastic material is from parts of the can lining which may peel off.

The affected 14.2 ounce SpaghettiOs Original product has a date of February 22, 2017 which is stamped on the base of the can, and a UPC code of 51000 22432 printed under the bar code.

The issue was identified after the company received consumer complaints.

This recall affects 355,000 cans and is limited to the United States.

This product should not be eaten. People who have bought the affected product should return it to the store where it was purchased for an exchange or full refund. For more information call 1-866-535-3774 between 9 a.m. to 7 p.m. EST, Monday to Friday or visit Facebook/SpaghettiOs. Campbell Soup Company apologizes for the inconvenience.

OC RAW DOG Voluntarily Recalls Limited Number of Raw Frozen Dog Food Due to Potential Salmonella Health Risk

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Santa Margarita, CALIFORNIA — OC Raw Dog of Rancho Santa Margarita, CA is voluntarily recalling 640 lbs. of Chicken, Fish & Produce Raw Frozen Canine Formulation. This is being done in an abundance of caution, as the product has the potential to be contaminated with Salmonella. No illnesses have been reported and no other OC Raw Dog manufactured products are affected.

Individuals handling raw pet food can become infected with salmonella, especially if they have not thoroughly washed their hands after having contact with the product or to surfaces exposed to the product. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments including arterial infections, endocarditis, arthritis, muscle pain, eye irritation and urinary tract symptoms. If a consumer exhibits these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may have decreased appetite, fever and abdominal pain. If left untreated, pets may be lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

This voluntary recall is limited to Chicken, Fish & Produce Raw Frozen Canine Formulations that were packaged into 6.5 lb. Doggie Dozen Patties, 4 lb. Doggie Sliders, and 3 lb. Meaty Rox with the lot number 1819, and use by date of 05/05/16. These codes can be checked on the bottom left corner of the back of the package. Distribution is limited to customers in Colorado, Vermont, and Pennsylvania and sold to consumers through independent pet specialty retailers.

The potential for contamination was noted after routine testing by the Colorado Department of Food and Agriculture of a sample that they collected at retailer revealed the presence of Salmonella in a 3 lb. bag of “Chicken, Fish & Produce Raw Frozen Canine Formulations” Meaty Rox. Another sample from the same lot was previously tested by the California Department of Agriculture and it had a negative Salmonella result.

If you are in possession of this recalled product please submit a picture of the package with the lot number to Olivia@ocrawdog.com for verification. Either dispose of the product immediately or return the product to the retailer where you purchased it for a replacement product.

Consumers with questions may contact the company at 1-844-215-DOGS (3647) Monday thru Friday 9am – 4pm PST. If you get our automated answering system please leave a message and we will call you right back.

At OC RAW DOG, we are passionate about our products and the safety of canine and human customers is our top priority. We apologize for any inconvenience this recall may have caused.
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Voluntary Recall for Navajo Pride Bleached Flour

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Farmington, NM — NAVAJO PRIDE, LLC of FARMINGTON, NM is issuing a voluntary recall of Bleached All Purpose Flour Lot#075B110064, expiration date 03162016 (“Product”) because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e. infected aneurysms), endocarditis and arthritis.

After conducting an internal investigation with assistance from third party advisory in food Quality Assurance, we are issuing a Voluntary Recall due to the low risk of the Product. Navajo Pride is providing full cooperation with the U.S. Food and Drug Administration and our certifying body the Safe Quality Food Institute (SQFI).

The potential for contamination was noted after routine testing by the company revealed the presence of Salmonella in a 5lb sample.

Product was delivered to regional retailers. No illnesses have been reported to date. Flour products are considered low risk due to the intended use as a cooking agent.

Navajo Pride, LLC is communicating with stores that have received the affected Product. Stores have been instructed to cease distribution of this Product and to remove the Product from store shelves.

Product comes in 5lb cloth bags, 25lb cloth bags, 50lb paper bags and is marked Navajo Pride with lot#075B110064 and an expiration date of 03162016.

Consumers that have the Product are urged not to eat it and to destroy the Product or return it to the point of purchase. Consumers with questions can contact Navajo Pride, LLC for further information at (505)566-2670 between the hours of 9:00AM and 5:00PM MST Monday-Friday. No other product by Navajo Pride is involved in this cautionary, voluntary recall.

TFH Publications, Inc./Nylabone Products Recalls Puppy Starter Kit

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puppy-fullTFH Publications, Inc./Nylabone Products, of Neptune, NJ is recalling one lot of its 1.69 oz. package of the Puppy Starter Kit dog chews, because they have the potential to be contaminated with Salmonella. Salmonella can affect animals ingesting the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The recalled Puppy Starter Kit consists of one lot of dog chews that were distributed nationwide, to Canada, and through one domestic online mail order facility.

The product comes in a 1.69 oz. package marked with Lot #21935, UPC 0-18214-81291-3, located on the back of the package, and with an expiration date of 3/22/18 also stamped on the back of the package.

The potential for contamination was noted after routine testing by the company revealed the presence of Salmonella in one lot of 1.69 oz. packages of the Puppy Starter Kit.

No illnesses have been reported to date in connection with this problem.

Consumers who have purchased 1.69 oz. packages of the Puppy Starter Kit from affected Lot 21935, UPC 0-18214-81291-3, Expiration date of 3/22/18, should discontinue use of the product and may return the unused portion to the place of purchase for a full refund. Consumers with questions may contact the company at 1-877-273-7527, Monday through Friday from 8:00 am – 5:00 pm Central time (after hours/weekends covered by third-party poison control center).

Aurora Products, Inc. Recalls Certain Walnuts and Trail Mixes Due to Possible Health Risk

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Orange, CT — Aurora Products, Inc. is conducting a voluntary nationwide recall of certain lots of NATURAL WALNUTS and TRAIL MIXES CONTAINING WALNUTS because they have the potential to contain Salmonella which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Product was distributed nationwide through retail stores. Product was also distributed in Canada and Bermuda.

No illnesses have been reported to date.

Aurora is communicating with stores that have received the affected product. Stores have been instructed to cease distribution of these products and to remove the affected product from store shelves.

The affected products were produced by Aurora Products, Inc. The potential for contamination was noted after routine testing by an outside company contracted by the FDA revealed the presence of Salmonella in one container of natural walnuts product. Organic walnuts are not affected.

Consumers that have the products listed below are urged to not eat it and destroy the product or return it to the point of purchase. Customers with questions can contact Aurora Products, Inc. for further information at (800)-898-1048 between the hours of 9:00AM to 5:00 PM EST Monday – Friday.
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