Tag Archives: Recall

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.

Halo, Purely for Pets® Issues Voluntary Recall of Sensitive Cat Turkey Dry Food Due to Mold

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ucm472417Halo, Purely for Pets has initiated a limited, voluntary recall of its Spot’s Stew Sensitive Cat Turkey kibble with a Best By date of 09/04/2016 due to reports of mold. No other Halo products are affected.

Consumers who have Spot’s Stew Sensitive Cat Turkey stamped “Best By 09/04/2016” should discontinue feeding, and return the remaining portion to any Halo retailer for a full refund or replacement.

While some pets can ingest mold without incident, others may experience digestive issues. Consumers should consult their veterinarian if their cat experiences digestive issues.
Halo is also instructing its retailers to remove Sensitive Cat Turkey products stamped “Best By 09/04/2016” from their shelves.

The affected product is:

Product name:
Spot’s Stew Wholesome Turkey Recipe Sensitive Formula for Cats

UPC Codes:
745158350231 and 745158340232

Sizes:
6 lb. and 3 lb. bags

Best by Date:
09/04/2016

For more information, contact Halo Customer Care at 800-426-4256 Monday-Friday 8:00 a.m. – 5:00 p.m. EST, or email customers@halopets.com or visit www.halopets.comdisclaimer icon.

Blue Buffalo Company, Ltd. Voluntarily Recalls Limited Production of Kitty Yums Chicken Recipe Cat Treats

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catyums-1Blue Buffalo Company, Ltd. is voluntarily recalling a limited production of Blue Kitty Yums Chicken Recipe Cat Treats that may contain low levels of propylene glycol, which is not permitted by the FDA for use in cat food.

Cats reacting to high doses of propylene glycol may exhibit signs of depression and may have a loss of coordination, muscle twitching, and excessive urination and thirst. If your cat has consumed the recalled product and has these symptoms, please contact your veterinarian.

The affected product was distributed nationwide in the US and Canada through pet specialty stores and e-commerce.

The product is packaged in a 2 oz., plastic stand up pouch. Only these specific code dates of this product are involved:

* Blue Kitty Yums Tasty Chicken Recipe, UPC: 859610007820 – Best If Used By: April 24, 2016.
* Blue Kitty Yums Tasty Chicken Recipe, UPC: 859610007820 – Best If Used By: July 24, 2016.

No other BLUE pet foods or treats are involved in this recall.

The FDA tested product in response to a single consumer complaint and found propylene glycol in one bag of our cat treats in the impacted lot. To date we have had no other reports of incidents related to our cat treats. Out of an abundance of caution, we are voluntarily recalling all product manufactured in the same lot as the subject bag.

Consumers who have purchased the product being recalled may return it to the place of purchase for a full refund. Consumers with questions may contact Blue Buffalo at: 888-667-1508 from 8 AM to 5 PM Eastern Time Monday through Friday and the weekend of November 7, 2015 or by email at BlueBuffalo5883@stericycle.com for more information.

David Trail Mix Sweet & Salty Voluntarily Recalled Due To Undeclared Dairy Allergen

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daves-1DAVID® Trail Mix Sweet & Salty flavor is being voluntarily recalled by ConAgra Foods of Omaha, Nebraska, due to the presence of an ingredient in the trail mix that contains milk protein, which is not declared on the packaging.

The finished product is made for ConAgra Foods by a third party supplier who is conducting a separate recall for similar, impacted products.

This food is a concern for people who are allergic to milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume the product. ConAgra Foods was made aware of this issue through a consumer contact. ConAgra Foods is aware of one consumer allergic reaction associated with consumption of this product.

ConAgra Foods is advising consumers who have purchased this item to discard it or return it to the store where originally purchased.

This recall includes the following DAVID Trail Mix Sweet & Salty products sold as part of multi variety packages that also contain DAVID Trail Mix Classic. DAVID Trail Mix Classic is not impacted by this recall.

The DAVID Trail Mix Sweet & Salty UPC is: 26200 23885, 5oz. bags/149g.

The product was shipped to retail food stores and distributors in the U.S. and Mexico. ConAgra Foods is working with retail customers and distributors to ensure the packages are removed from store shelves.

This recall is limited to DAVID Trail Mix Sweet & Salty flavor only and does not impact other flavors of DAVID Trail Mix or any DAVID Seeds products.

Consumers with questions should call our Consumer Affairs hotline at: (800) 881-3989, open 24 hours a day/7 days a week.

General Mills Issues Voluntary Recall Of Cheerios And Honey Nut Cheerios Cereal

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800-cheerios-1MINNEAPOLIS, Minnesota — General Mills is voluntarily recalling several days of production of Cheerios and Honey Nut Cheerios cereal produced at its Lodi, California facility on certain dates in July of this year because of an undeclared allergen – wheat – with potential adverse health effects.

Cheerios and Honey Nut Cheerios produced on these dates at the company’s Lodi, California facility are being recalled because an isolated incident resulted in wheat flour being inadvertently introduced into the gluten free oat flour system at its Lodi facility. As a result, the products may contain an undeclared allergen – wheat – in products labeled as gluten-free.

General Mills will recall and retrieve affected cereals produced on those dates from customer warehouses and store shelves. Consumers with wheat allergies, celiac disease or gluten intolerance should not consume products bearing the affected code dates and should contact General Mills for a replacement or full refund.

This voluntary recall includes four days production of original (yellow box) Cheerios, and thirteen days of production of Honey Nut Cheerios at its Lodi, California facility with the following “BETTER IF USED BY” code dates and the plant code LD which indicates the product was produced at Lodi, California:

Honey Nut Cheerios
12JUL2016LD, 17JUL2016LD, 23JUL2016LD, 13JUL2016LD, 18JUL2016LD, 24JUL2016LD, 14JUL2016LD, 20JUL2016LD, 25JUL2016LD, 15JUL2016LD, 21JUL2016LD, 16JUL2016LD, 22JUL2016LD

Yellow Box Cheerios
14JUL2016LD, 15JUL2016LD, 16JUL2016LD, 17JUL2016LD

Products containing wheat can cause illness or severe reactions for individuals with wheat allergies or celiac disease. Products containing wheat can also cause illness or discomfort for individuals with gluten intolerance.

General Mills is transitioning five varieties of Cheerios to gluten free. Cheerios and Honey Nut Cheerios cereals produced at General Mills’ other facilities, or on dates other than those noted at the Lodi, California facility, are not impacted. General Mills’ other gluten-free Cheerios varieties – including Apple Cinnamon Cheerios, Frosted Cheerios and MultiGrain Cheerios – are not impacted and are not being recalled. No other General Mills cereals are affected

Consumers requesting refunds or calling with further questions should contact General Mills Consumer Services at 1-800-775-8370.