Category Archives: Recall

Kraft Foods Group Voluntarily Recalls Select Kraft Macaroni & Cheese Boxed Dinners Due to Possible Metal Pieces

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ucm438726NORTHFIELD, Ill. — Kraft Foods Group is voluntarily recalling approximately 242,000 cases of select code dates and manufacturing codes of the Original flavor of Kraft Macaroni & Cheese Dinner – due to the possibility that some boxes may contain small pieces of metal. The recalled product is limited to the 7.25-oz. size of the Original flavor of boxed dinner with the “Best When Used By” dates of September 18, 2015 through October 11, 2015, with the code “C2” directly below the date on each individual box. The “C2” refers to a specific production line on which the affected product was made.

Some of these products have also been packed in multi-pack units that have a range of different code dates and manufacturing codes on the external packaging (box or shrink-wrap), depending on the package configuration (see table below).

Recalled product was shipped to customers in the U.S. and several other countries, excluding Canada. The affected dates of this product were sold in only these four configurations:

  • 7.25 oz. box, Original flavor
  • 3-pack box of those 7.25 oz. boxes, Original flavor
  • 4-pack shrink-wrap of those 7.25 oz. boxes, Original flavor
  • 5-pack shrink-wrap of those 7.25 oz. boxes, Original flavor

The following is being recalled:

Product Size Name of Product Sell Unit Best When Used By Code Date & Mfr. Code Individual Box Best When Used By Code Date & Mfr. Code Individual Box UPC Multi-Pack Unit UPC
7.25 oz. each Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 NA 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 NA
3-Pack Box
(Three 7.25 oz. Boxes)
Net Wt. 21.75 oz.		 3-Pack Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 09 SEP 2015 XDG
27 SEP 2015 XDG
01 OCT 2015 XDG
02 OCT 2015 XDG
03 OCT 2015 XDG
20 NOV 2015 XDG		 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 0 21000 05076 5
4-Pack
Shrink–wrap
(Four 7.25 oz. Boxes)
Net Wt. 29 oz.		 4-Pack Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 18 SEP 2015 C2
19 SEP 2015 C2
08 OCT 2015 C2		 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 0 21000 72540 3
5-Pack
Shrink-wrap
(Five 7.25 oz. Boxes)
Net Wt. 36.25 oz.		 5-Pack Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 18 SEP 2015
through
11 OCT 2015
XAR or C2		 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 0 21000 77436 4

No other sizes, varieties or pasta shapes and no other packaging configurations are included in this recall. And no products with manufacturing codes other than “C2” below the code date on the individual box are included in this recall.

Kraft has received eight consumer contacts about this product from the impacted line within this range of code dates and no injuries have been reported. We deeply regret this situation and apologize to any consumers we have disappointed.

The recalled product was shipped by Kraft to customers nationwide in the U.S. The product was also distributed to Puerto Rico and some Caribbean and South American countries — but not to Canada.

Consumers who purchased this product should not eat it. They should return it to the store where purchased for an exchange or full refund. Consumers also can contact Kraft Foods Consumer Relations at 1-800-816-9432 between 9 am and 6 pm (Eastern) for a full refund.

Frontier Co-op Initiates Voluntary Class 1 Recall Due to Possible Health Risk from Organic Garlic Powder

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recall-3Frontier Co-op is voluntarily recalling several of its products manufactured with organic garlic powder that were sold under its Frontier and Simply Organic brands, and one product sold under the Whole Foods Market brand due to potential Salmonella contamination. To date, no illnesses have been associated with these products.

The product in question was raw material received by Frontier, which tested positive for Salmonella during a test by the United States Food and Drug Administration. Given that Salmonella may be present, Frontier is immediately initiating this recall.

Frontier Co-op is immediately initiating added precautions to the safety of the supply chain and instituting additional product testing, beyond FDA guidelines, to mitigate any future occurrence.

Consumption of products containing Salmonella 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, 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, endocarditic and arthritis.

Recalled products were sold in all 50 states and in some parts of Canada to distributors, retailers and consumers. Below the release is a list of products containing the organic garlic powder. Images of the affected products can be viewed at the following link: http://www.frontiercoop.com/recalldisclaimer icon.

On foil bulk packages, the four-digit lot code will be found on the front label directly above the UPC code. On bottled items, the four-digit lot code can be found on the bottom of the bottle. On seasoning mixes, the four-digit lot code is embossed on the right side of the packet.

Consumers should not consume these products and should either throw away any remaining products or return to the point of purchase for a refund.

Please contact Frontier Co-op with any questions or to inquire about replacement or reimbursement at 1- 800-669-3275 Monday through Friday from 8:00 a.m. to 5:00 p.m. Central time.
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Primal Pet Foods Voluntarily Recalls A Single Lot of Raw Frozen Cat Food

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300-PrimalPrimal Pet Foods is voluntarily recalling a single batch production code of Feline Turkey Raw Frozen Formula 3-pound bag. FDA tested product in response to a single consumer complaint. Primal Pet Foods was alerted by FDA that the testing of two bags of this lot resulted in a low thiamine level. Neither FDA nor Primal have received any other reports concerning Thiamine in Primal products. No other product manufactured by Primal Pet Foods is involved in this voluntary recall.

Cats fed only diets low in thiamine for several weeks may be at risk for developing a thiamine deficiency. Thiamine is essential for cats. Symptoms of deficiency displayed by an affected cat can be gastrointestinal or neurological in nature. Early signs of thiamine deficiency may include decreased appetite, salivation, vomiting, and weight loss. In advanced cases, neurologic signs can develop, which may include ventriflexion (bending towards the floor) of the neck, wobbly walking, circling, falling, and seizures. If your cat has consumed the recalled lot and has these symptoms, please contact your veterinarian. If treated promptly, thiamine deficiency is typically reversible.

Only the product with the following Best By date and production code is included in the voluntary recall. It is best to check the production code on the back of the bag to determine if the product has been recalled or not.

The lot involved in this voluntary recall is:

Primal Pet Foods Feline Turkey Raw Frozen Formula 3-pound bag (UPC# 8 50334-00414 0) with Best By date 060815 B22

Primal takes very seriously, the need for adequate Thiamine levels in our feline diets. We include Organic Quinoa Sprout Powder as a natural B-Complex supplement to ensure that adequate levels of Thiamine are met. Additionally, Thiamine occurs naturally in other ingredients contained in our Feline Turkey Formula such as: Turkey Muscle Meat (including heart), Turkey Liver, Organic Sunflower Seeds, Dried Organic Kelp, Organic Collard Greens and Organic Squash.

Consumers who still have bags of cat food from this lot should stop feeding it to their cats and call us at (866) 566-4652 Monday through Friday, 9:00 am – 4:00 pm PST. Consumers with further questions should visit our website at www.primalpetfoods.com or call us at this same number.

Ultra ZX LABS, L.L.C. Issues Voluntary Nationwide Recall of Ultra ZX

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300-ultraZX-1MIAMI, Fl — UltraZx, Labs, L.L.C. is voluntarily recalling “UltraZx” weight loss supplements. This product has been found to contain undeclared Sibutramine and phenolphthalein.

FDA laboratory analysis of confirmed that UltraZx contains sibutramine and phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because 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 a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer causing risk. This product may also interact, in life-threating ways, with other medications a consumer may be taking.

Ultra ZX LABS, L.L.C. has not received any reports of adverse events related to this recall. UltraZx weight loss supplement is marketed as a dietary supplement used as a weight loss aid and is packaged in bottles of thirty (30) capsules of 300mg. The affected UltraZx weight loss supplement, includes all lots/bottles/packages. The products were distributed from September 2014 until February 2015.

UltraZx Labs, L.L.C. is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers and distributors that have product which is being recalled should stop using the product and return the product to UltraZx Labs, L.L.C.

Consumers with questions regarding this recall can contact UltraZx Labs, L.L.C. at (305) 904-9393, Monday through Friday from 9:00am – 5:00pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

This recall is being conducted with the knowledge of the Food and Drug Administration (FDA).

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.

Dream on Me Recalls 2-in-1 Bassinet to Cradle Due to Fall and Suffocation Hazards

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Baby-Buggies1This recall involves the 2-in-1 Bassinet to Cradle, sold in pink, blue, green, and white manufactured in China. The bassinets were sold online at Amazon.com, Walmart.com, Wayfair.com, ToysRUs.com and Kohls.com from May 2012 to October 2014 for about $60.

Dream on Me has received one incident of the wire frame support bracket failing and the fabric portion of the bassinet collapsing while an infant was asleep in the cradle. No injuries have been reported.

The bassinet has metal frame supports and fabric sides with a removable half-canopy on the top. The frame can also be adjusted with two rocking legs on each end of the bassinet. It is designed with fabric handles and the option to remove the bassinet from the frame to use the bassinet portion as a “by the bed” sleeper product. The recalled model numbers are 439-A, 439-B, 439-G, 439-P and 439-W and can be found on a tag which is located under the mattress pad of the bassinet. This tag is a removable tag you see in the store but is removed prior to use.

Consumers should immediately stop using the product and contact Dream On Me to obtain a free repair. In the meantime, parents are urged to find an alternate, safe sleeping environment for the child, such as a crib that meets current safety standards or play yard depending on the child’s age.

Consumers can contact Dream on Me toll-free at (877) 201-4317, from 9 a.m. to 4:30 p.m. ET Monday through Friday, or online at www.dreamonme.com and click on the “Recalls” icon on the home page for more information.

Children’s Pajamas Recalled by KTM North America for Violation of Federal Flammability Standard

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pajamas-1This recall involves children’s onesies and two-piece KTM motocross pajamas manufactured in China. The pajamas fail to meet federal flammability standards for children’s sleepwear, posing a risk of burn injuries to children.

The Baby Racing Body onesies are 95% cotton and 5% elastane and were sold in three prints. One is orange with white sleeves and the KTM brand logo on the left chest. The second is white and orange with the KTM brand logo in bold orange printed on the center front of the chest and on the left and right hip. The third onesie is yellow with orange and black detailing and the KTM brand logo printed on the left. All onesies are long-sleeved and have snap closures from the neck to the left ankle and were sold in sizes 18 months to 2T.

The two-piece, long-sleeve and pant pajama sets are 100% cotton and were sold in two prints. The Kids Racing Gear pajama is white with black, orange and grey detailing on the top and pant with a black elastic waistband and KTM printed on the left side of the chest. This set was sold in sizes 2T through 5T. The Kids Gravity Gear pajama two-piece set is white with blue, and orange detailing on the top and pant with an elastic waistband in orange and KTM printed on the left side of the chest and on the right hand wrist. This set was sold in sizes XXS through L.

No injuries have been reported.

Sold at authorized KTM motorcycle shops nationwide from August 2012 through January 2015 for between $28 and $32.

Consumers may contact KTM North America, Inc. toll-free at (888) 985-6090 from 9 a.m. to 5 p.m. ET, Monday through Friday or online at www.ktmusa.com and click on “Recall Information” link at the bottom of the page for more information.

Maternal Science, Inc. Issues Allergy Alert on Undeclared Milk in Healthy Mama® Boost It Up!™; Mango Drink

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HMBoostNew5595-sq300Maternal Science, Inc. of Montvale, NJ, is voluntarily recalling healthy mama® Boost It Up!™ Drink because it contains undeclared milk (whey protein isolate). People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. healthy mama® Boost It Up!™ Drink is manufactured for and distributed by Maternal Science, Inc. and sold nationwide through limited retailers and via internet sales. healthy mama® Boost It Up!™ Drink is packaged in a plastic bottle with a white label containing 12 fl oz per bottle (see labels below). The affected lots entered the marketplace on April, 2014. The lots affected are listed below.

Product name Package Size Lot# Date Best By UPC Code
healthy mama® Boost It Up! Mighty Mango with Ginger 12 fl oz. 14275-11 bottle 10/2015 810758020058
healthy mama® Boost It Up! Mighty Mango 12 fl oz. 14090-11 bottle 03/2015 810758020058

To date no illnesses have been reported. The recall was initiated after it was discovered during an internal review that healthy mama® Boost It Up!™ Drink containing whey protein isolate (milk) was distributed in packaging that did not reveal the presence of milk. Consumers who are allergic to milk and purchased healthy mama® Boost It Up!™ Drink are urged not to consume the product.

Consumers who purchased the affected lots of healthy mama® Boost It Up!™ Drink may return it to: ATTN: BOOST IT UP RETURN, 225 Long Ave, Hillside, NJ 07205 for a full refund or exchange. Customers may contact the company at (855) 773-4426, Monday–Thursday, 9AM – 5PM, ET or email Inquiries@healthymama.com for further instructions and claim processing.

Heritage Pharmaceuticals Initiates a Nationwide Voluntary Recall of Colistimethate for Injection

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heritage-1

Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Both products are sold in single vial mono-cartons in case packs of ten (10). Heritage has initiated this voluntary recall of Colistimethate for Injection, USP, 150 mg Single-Dose vial and Rifampin for Injection USP, 600 mg Single-Dose vial to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility.

Intravenous administration of non-sterile injection products to a normally sterile site may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or fatal outcome. To date, Heritage is not aware of any adverse patient events resulting from the use of the subject product lots.

The lot numbers with expiry date being recalled are: Colistimethate for Injection

Lot No.
VCOA002
VCOA003
VCOA004
VCOA005
VCOA006
VCOA007
VCOA008
VCOA009
VCOA010
VCOA011		 Exp. Date
9/30/2014
10/31/2014
10/31/2014
1/31/2015
3/31/2015
9/30/2015
12/31/2015
2/29/2016
10/31/2016
10/31/2016

Rifampin for Injection

Lot No.
VRIA002
VRIA003
VRIA004		 Exp. Date
8/31/2016
9/30/2016
9/30/2016

The products were distributed to hospitals, wholesalers and distributors nationwide from December 2012 through January 2015 (Colistimethate) and from October 2014 through January 2015 (Rifampin). Colistimethate is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacteria. Rifampin is indicated for the treatment of all forms of tuberculosis.

Customers are being notified by fax, email, UPS, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return the recalled lots of product. Customers who may have further distributed these products have been requested to identify their customers and notify them at once of this product recall.

Any questions about returning unused product should be directed to the customer call center at (866) 901-1230 M-F 9am-5pm EST. Healthcare workers who have medical questions about Colistimethate for Injection, USP, 150 mg base/vial and Rifampin for Injection USP, 600 mg/vial may contact Heritage Medical Affairs (732-429-1000, Ext. 101) M-F 9am-5pm EST.

Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection

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FDA-Recall-MedSchaumburg, ILLINOIS – Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility. Non-sterility of a drug administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Sagent has transferred the manufacture of this product to its own facility and this product manufactured at the Sagent facility will not be impacted by the recall.

Sagent is not aware of any adverse patient events resulting from the use of the subject product lots.

The lot numbers being recalled are VATA012, VATA015 (50mg/5mL) and VATB012, VATB013, VATB014, VATB017 (100mg/10mL) which were distributed to hospitals, wholesalers and distributors nationwide from February 2014 through February 2015. Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation, and is supplied in single-dose and multi-dose vials.

Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.comdisclaimer icon.

Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about Atracurium Besylate Injection, USP may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-5pm CST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Urgent: El Popocatepetl Ind., Inc. issues an allergy alert on Sundried Tomato, Spinach Pesto, and Chipotle Wraps

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wraps-1

El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl’s 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain undeclared milk and Yellow #5. People who have allergies to milk and/or Yellow #5 run the risk of serious or life-threatening allergic reaction if they consume these products.

El Popocatepetl’s 8in. Flavored Wraps were distributed in the state of Illinois, primarily in the Chicago area.

The information on how the recalled products can be identified is listed below:

Product Name: 8in. Sundried Tomato
Brand Name: El Popocatepetl
Description: 8in. Tomato Flavored Wrap
UPC: 0 20784 99505 7
Any Product with the Best By Date of
April 1, 2015 and Before.
Product Name: 8in. Spinach Pest
Brand Name: El Popocatepetl
Description: 8in. Spinach Flavored Wrap
UPC: 0 20784 58314 8
Any Product with the Best By Date of
April 1, 2015 and Before.
Product Name: 8in. Chipotle
Brand Name: El Popocatepetl
Description: 8in. Chipotle Flavored Wrap
UPC: 0 20784 78248 0
Any Product with the Best By Date of
April 1, 2015 and Before.

The recall was initiated during a review of the product ingredients and the labeled ingredients revealed milk and Yellow #5 was present in an ingredient used to make the flavored wraps but not listed as ingredients on the labels. No Illnesses have been reported to date.

All recalled products are being removed from the store shelves. No other El Popocatepetl products are involved in this recall.

Consumers who have purchased the recalled product can return it to the place of purchase for a full refund. Consumers with questions may contact the Company Consumer Department at 773-843-0888.