Tag Archives: Recall

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.

Hummingbird Wholesale Issues Allergy Alert on Undeclared Milk in Organic Chocolate Hazelnut Butter

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hummingbird-1WASHINGTON — Hummingbird Wholesale in Eugene Oregon is recalling 110 jars of Hummingbird Brand Organic Chocolate Hazelnut Butter that may contain undeclared milk. People who have an allergy or severe sensitivity to milk products run the risk of serious or life threatening allergic reaction if they consume this product.

No illnesses have been reported to date.

The recalled product sold to retail outlets in California, Oregon, and Washington and directly to consumers in Oregon in 1 pound (454 gram) glass jars that show lot number of 15023 on a white sticker on the jar between the dates of 1/27/15 and 2/19/15.

HW Item # Lot # UPC Code
N270 15023 6-96859-11035-1

The recall was initiated after it was discovered that a supplier had changed the ingredients without notice to include milk in the 65% dark chocolate used to make the Organic Chocolate Hazelnut Butter. The label does not show milk as an ingredient. Only lot # 15023 was made with the affected chocolate.

Consumers who purchased this product are welcome to return it to the place of purchase for a full refund, or to contact Hummingbird at 541-686-0921 ext. 105 from 8am to 4pm PST Monday through Friday.

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

Hummingbird Wholesale has taken immediate action to recall the affected Organic Chocolate Hazelnut Butter in order to ensure the safety of its consumers.

Hummingbird Wholesale is dedicated to providing the highest quality organic and raw products, and the safety of our customers is our number one priority.

ESS Food Recalls Pork Products Produced Without Benefit of Import Inspection

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USDA-RECALL-1WASHINGTON – ESS Food, a Danish establishment, is recalling approximately 50,904 pounds of pork belly product produced in Poland that was not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Without the benefit of full inspection, a possibility of adverse health consequences exists.

The boneless pork belly was produced on various dates from March 3, 2014 to April 11, 2014. The following product is subject to recall:

Approximately 40-lb. boxes containing 4-5 pieces of “PINI POLONA PORK BELLY BONELESS”

The products subject to recall bear the establishment number “10023802” inside the Polish mark of inspection. The products were shipped to a distributor in Texas and a processing facility in Iowa.

The problem was discovered during routine surveillance of storage facilities when an FSIS investigator observed that the products lacked USDA import inspection marks.

This is a Class I Recall which indicates a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Consumers or Media with questions about the recall can contact Michael Stentebjerg, Area Manager, at (404) 254-8510.

California Firm Recalls Beef Products Produced Without Benefit of Import Inspection

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chicken-1WASHINGTON – ATM International USA, Inc., a Torrance, Calif. establishment, is recalling approximately 1,999 pounds of boneless beef products that were not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Without the benefit of full inspection, a possibility of adverse health consequences exists.

The boneless beef products were imported from Japan on various dates between Oct. 9, 2014 – Jan. 15, 2015, and labeled in Japanese only.

  • Various weights and cuts of vacuum packed chilled boneless beef.

The vacuum packaging bears the Japanese translation for the following cuts:

  • Tender loin
  • Strip loin
  • Ribeye
  • Chuck Roll
  • Top Sirloin Butt
  • Chuck Ribs
  • Bottom Round
  • Top Round
  • Clod
  • Brisket
  • Short Plate
  • Short Rib
  • Knuckle

The above products would have been shipped either inside of a cardboard box with the Japanese establishment number “M2” and a box marking of “MZA-TN41”, “MZA-TN28” or “MZA-TN1” or inside of a Styrofoam box bearing the establishment number “EST. 27510” inside the USDA mark of inspection. These products were shipped to distributors and retail locations in Arizona, California, and Washington.

The problem was discovered during routine review of product tracking records.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.