Category Archives: Recall

Recall of Assured™ Brand Naproxen Sodium Tablets due to Packaging Mix-Up

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14974962224_4113b8a58b_mGREENSBORO, N.C. – Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured™ brand Naproxen Sodium tablets because some cartons actually contain bottles of Ibuprofen, a different pain reliever. The Ibuprofen bottles were placed in the Naproxen Sodium boxes due to a packaging error. The affected products are: boxes of Assured™ brand Naproxen Sodium Tablets 220mg, 15 count (Lot #FH4102A) [SKU #122368/UPC #639277223685] containing bottles of Ibuprofen softgels in 200mg strength.

Consumers who intentionally avoid using Ibuprofen due to allergy, or other medical conditions, should be advised that they may have inadvertently purchased Ibuprofen 200mg softgels, believing it was Naproxen Sodium 220mg tablets. Allergic reactions can range from mild irritation or hives to serious reactions such as anaphylaxes that may be life-threatening. The firm has not received any reports of adverse events related to this recall.

The recalled Assured brand drug products were distributed nationwide to Dollar Tree® and sold via the Dollar Tree® retail stores and internet site. Contract Packaging Resources is notifying its distributors and customers directly and arranging for replacement of all recalled products. Consumers may return the recalled products to the place of purchase or contact the firm by phone at 336-252-3422, on Monday – Friday from 8:00 am to 4:00 pm (Eastern).

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. 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.

Maryland Firm Recalls Lamb Products Produced Without Import Inspection

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WASHINGTON – – E.&B.’s Natural Way, a Frederick, Md. establishment, is recalling approximately 27,948 pounds of raw lamb products because they were not presented at the border for USDA-FSIS Import 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 lamb products were packaged on October 21, 2013, September 2, 20, 21 and 22, 2014. The following products are subject to recall:

  • Lamb Packs
  • Lamb Bone-In Legs
  • Lamb Boneless Legs
  • Lamb Saddles
  • Lamb Racks
  • Lamb Loins
  • Lamb Shoulders
  • Lamb Shanks
  • Lamb Trim
  • Lamb for Stew

The products subject to recall bear the establishment number “IS A022 EFTA” and include a label indicating “Product of Iceland.” These products were shipped to retail establishments in Washington and Oregon where the products would have been repackaged.

The problem was discovered during a routine review using the Automated Commercial Environment (ACE) database. ACE is a web-based portal for the collection and use of international trade data maintained by U.S. Customs and Border Protection. The failure-to-present was the result of the importing establishment not following appropriate procedures.

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.

FSIS issues a Public Health Alert for an imported product when the country of origin recalls the product. FSIS issues a recall for imported product when the product is not presented for inspection at the U.S. border.

A failure-to-present (FTP) occurs when importers fail to present a shipment to FSIS for import inspection prior to the product entering U.S. commerce. Failure-to-present will result in the recall of the product.

Consumers and media with questions about the recall can contact Blair Gordon, Owner, at (301) 471-5615.

AMS Health Sciences, LLC Issues Voluntary Recall of Saba Shark Cartilage Complex

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101031Oklahoma City, Oklahoma — AMS Health Sciences, LLC is notifying the public that it is recalling 2014 bottles of Saba Shark Cartilage Complex due to possible contamination of 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. To date, no illness or complaints have been reported to AMS Health Sciences, LLC.

A single lot of Saba Shark Cartilage Complex is the subject of this public announcement and recall as a result of a sample from one bottle that tested positive for Salmonella. This product is packaged in black screw-top bottles with the brand name “saba” in red letters, the product name “shark cartilage complex” in white letters, and a net quantity statement of “500 mg 60 capsules” in small white letters. Product from the affected lot can be identified by the Lot Number 416349 and an expiration date of 08/16, both of which are printed in black letters inside a white rectangle that is adjacent to the products “Suggested Use” instructions.

Product from this lot was sold to consumers through the internet site www.sabaforlife.com during the period of February through August 2014. AMS is initiating this recall out of caution for consumer health, even though numerous samples from the same Lot No. have tested negative for Salmonella.

Any consumer who purchased product with the lot number and expiration date above should dispose of it immediately and may request a refund by calling (866) 758-7222, Monday through Friday, 9:00 am – 5:00 pm (Central). If you have consumed the product and are experiencing any unusual or severe symptoms such as those described above, go to an emergency room immediately or contact your physician for immediate advice.

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.

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

JFC International Inc. Issues Allergy Alert on Undeclared Milk in “Hapi Pudding”

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ucm419328JFC International Inc. of Los Angeles, CA is voluntarily recalling all lot codes of its 3-pack Hapi Pudding with a net weight of 8.46 ounces (UPC 11152 13417), because they may contain undeclared milk. People who have allergies to milk run the risk of a serious or life-threatening allergic reaction if they consume the products.

The recalled product, “Hapi Pudding” was distributed nationwide to retail stores.

The product comes in a pack of three, weighing a total of 8.46 ounces, in clear plastic containers, with an orange and white seal on the top. The seal has the words “Hapi Pudding” with an image of a pudding. The 3 pack of pudding is plastic wrapped, with the product information found at the bottom of the product.

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

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

JFC has immediately responded to this issue and have already taken action to stop sales and distribution of the affected product.

Consumers who have purchased the product “Hapi Pudding” are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-633-1004, Monday – Friday, 8:30am-5pm PST.
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Massachusetts Firm Recalls Chicken Products Due to Possible Misbranding and Undeclared Allergen

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WASHINGTON – Shop Packaging LLC, a New Bedford, Mass. establishment, is recalling approximately 115,505 pounds of chicken wing products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products were processed with a releasing agent containing soy lecithin, a known allergen which is not declared on the product label.

This is a Class II recall which is a health hazard situation where there is a remote probability of adverse health consequences from the use of the product.

The chicken wing products were produced on various dates between August 8 and October 10, 2014. The following product is subject to recall:

  1. 20-lb. bags containing “Chicken Mid-joint Wing.”

The products subject to recall bear the establishment number “P-46946” inside the USDA mark of inspection. These products produced were shipped to a distribution location in New York.

The problem was discovered by a FSIS inspector. The company sprayed a vegetable and canola oil, which contains soy lecithin, on their conveyor belt. FSIS has determined that the spray has been used since August 8th of this year.

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

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Consumers and media with questions about the recall can contact Ron Sylvia, President, at (508) 961-7552.

Consumers with food safety questions can “Ask Karen,” the FSIS virtual representative available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday.

New Hope Mills Issues Allergy Alert on Undeclared Soy in New Hope Mills Gluten Free Chia Pancake and Waffle Mix

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FDA Photo. Click for larger view.

FDA Photo. Click for larger view.

WASHINGTON – New Hope Mills Manufacturing of Auburn, NY is recalling all Gluten Free Chia Pancake and Waffle Mix because it may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

New Hope Mills Gluten Free Chia Pancake and Waffle Mix was distributed to distributors and retailers in NY, PA, NH, OK, and FL.

The affected product, New Hope Mills Gluten Free Chia Pancake and Waffle Mix, can be identified as a 16 OZ bag in a boxboard box. The box itself is primarily red and white, and includes on the front of box, the New Hope Mills logo along with a picture of the Chia Pancakes. The UPC code on the box reads “07470353012”. The boxes affected will have one of the following “Best By Dates” on the bottom of the box: 11/13/2014, 11/14/2014, 2/26/2015, 7/29/2015, 10/4/2015, 12/13/2015

No illnesses have been reported to date.

New Hope Mills was contacted on 10/15/2014 by The Raymond-Hadley Corp., the Contract Manufacturer of New Hope Mills Gluten Free Chia Pancake and Waffle Mix. The Raymond-Hadley Corp. notified New Hope Mills that they had discovered that New Hope Mills Gluten Free Chia Pancake and Waffle Mix was made with an ingredient containing soy and was produced and distributed in packaging that did not reveal the presence of soy.

Consumers who have purchased New Hope Mills Gluten Free Chia Pancake and Waffle Mix are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 315-252-2676. Monday – Friday, 8am-4pm, EST.

Hospira Announces Voluntary Nationwide Recall of Certain Lots of Several Lifecare Products Due to Potential for Leakage

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200px-medicalDirectorsHospira, Inc. (NYSE: HSP), today announced the voluntary recall of certain lots of several products in its LifeCare™ line of flexible intravenous solutions due to the potential for leakage. The issue, which Hospira notified customers about in a Dear Health Care Provider letter issued earlier this year, was identified during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container.

The puncture in the primary container may result in leakage that is difficult to detect. Leakage may result in an open system, which has the potential for contamination, compromised sterility, drug waste, spillage, inadequate or inconsistent solution/medication dosing, and/or delay in therapy, all of which may require medical intervention and should be reported to Hospira and/or the U.S. Food and Drug Administration (FDA). Hazardous topical exposure may occur if a hazardous drug is added to the flexible container. Hospira’s product insert packaged with LifeCare flexible intravenous containers recommends providers do not administer unless solution is clear and the container is undamaged.

The root cause is attributed to a defect in a conveyance system, and corrective actions have since been implemented to prevent a reoccurrence. To date there have been no reports of adverse events associated with this issue for the impacted lots. The manufacturing issue that caused this incident has been addressed. Hospira recommends impacted customers check with their local Hospira representative or with Hospira Customer Care regarding replacement product.

The affected lots were originally distributed by Hospira to direct accounts from September 2013 through October 2014. The full lot list can be found at this web site.

Covidien Initiates Voluntary Field Safety Alert for Multi-function Defibrillation Electrodes

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Sample photos from Coviden web site. For illustration only. Contact Coviden for exact models effected by recall.

Sample photos from Coviden web site. For illustration only. Contact Coviden for exact models effected by recall.

Dublin, Ireland — Covidien today announced that it has notified customers of a voluntary Field Safety Alert for certain Medi-Trace™ Cadence and Kendall™ Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillators.

These electrodes will not connect with Philips FR3 or FRx AED units, and in the case of the use of Covidien defibrillation electrodes with the Philips FR3 AED units, could result in a delay of therapy. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user will not discover the compatibility issue until the AED must be used. This may result in a delay in therapy.

Philips FR3 and FRx AED units should only be used with the Philips brand electrodes specified in the equipment manual.

Covidien has received two reports where customers attempted to use a Covidien electrode with a Philips FR3 AED unit. The mismatch of these devices contributed to a delay in resuscitation and may have contributed to the subsequent death of one patient.

Covidien alerted customers to the this issue by letter on September 18, 2014, and has revised labeling to clarify that use of these electrodes is incompatible with Philips FR3 and FRx AED units.

The Field Safety Alert requests that customers review the use of Covidien defibrillation electrodes in their facility to assure that Covidien electrodes are not placed for use with Philips model FR3 or FRx AEDs.

There are a total of 644,460 electrodes affected by this safety alert.

The following Covidien electrodes are affected:

  • 22660R – Medi-Trace™ Cadence Adult Multi-Function Defibrillation Electrodes Radiotransparent
  • 22660PC – Medi-Trace™ Cadence Adult Multi-Function Defibrillation Electrodes Pre-connect
  • 20660 – Kendall™ Adult Multi-Function Defibrillation Electrodes
  • 40000006 – Kendall™ 1710H Multi-Function Defibrillation Electrodes

In addition, similar private label electrodes produced by Covidien were also distributed under the following brands, and have the same connector compatibility issue:

  • MC1710H – MediChoice® Multifunction Electrode
  • M3718A – Philips HEARTSTART Multifunction Electrode Pads

The Field Safety Alert applies to all lot numbers distributed globally.

The Food and Drug Administration has classified this as a Class 1 Recall, the most serious recall where there is a reasonable risk of a serious adverse health consequences or death.

For further information or to report a problem, please contact Covidien Quality Assurance at 1-800-962-9888, option 8, then extension 2500 between the hours of 8 a.m. and 5 p.m. (eastern) or email Mansfield.productmonitoring@covidien.com

Dimension Industries Recalls Sling Café Sets Due to Fall Hazard

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DimensionTableChairSet640Dimension Industries is recalling about 18,000 sling café sets manufactured by Foshan Shunde Shian Furniture Co Ltd., of China. They were sold exclusively through Costco Wholesale stores nationwide from December 2013 through May 2014 for about $400.

The three-piece sling fabric café sets include two aluminum swivel chairs with medium brown-colored stretched fabric seats and backs, a round aluminum base and aluminum arm rests, and a rectangular table with a tabletop made from porcelain tile with a natural stone look. The chairs are about 44 inches H x 26 inches L x 30 inches W. The table is about 29 inches H x 30 inches L x 26 inches W. Costco Item #966710 is printed on the hangtag, label and on the packaging.

The recalled chairs can break due to a missing metal washer plate, posing a fall hazard to consumers. Consumers should immediately stop using the chairs and contact Dimension to receive a free repair kit or a full refund. Consumers can contact Dimension at Dimension at (800) 598-6532 from 9 a.m. to 5 p.m. ET.

DimensionWasherPlate640

Number-966630-fairview-7Costco is also recalling the Agio Fairview 7 Piece Woven Dining Set, Costco Item Number 966630.

There have been reports that the legs of the chairs can fracture, causing the chair to bend or fall backward, and presenting a possible risk of injury from a fall.

The units were sold from between January 2014 and March 2014 and also distributed by Dimension Industries of Taiwan. Consumers should return the product to Costco or contact Agio at 1-800-598-6532 to arrange a pickup.

Real Foods Of Seattle, LLC Issues Allergy Alert On Undeclared Egg In Mexican Cheddar Dip

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ucm418650October 12, 2014 – Real Foods of Seattle, LLC, (WA) is initiating a voluntary recall of 96 units of “Mexican Cheddar Dip” product due to an undeclared allergen. This product contains egg, an allergen, which is not declared on the bottom label. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product.

The product subject to the recall:

STORE ITEM DESCRIPTION UPC NUMBER SELL BY DATE
QUALITY FOOD CENTERS 10-oz package of Mexican Cheddar Dip 0 30223 00952 8; or
0 30223 00968 9 10/09/14;		 10/10/14;
10/11/14.

The above product was manufactured between 10/04/14 and 10/06/14 and shipped between 10/05/14 and 10/07/14 to a limited number of QUALITY FOOD CENTER stores in Washington State only. The newly launched product may bear one of the two UPC numbers listed in the table.

This product was distributed and sold in a limited number of Quality Food Center stores in the following cities: Everett, (WA); Mill Creek, (WA); Sequim, (WA); Bothell, (WA); Port Townsend, (WA); Belfair, (WA); Lacy, (WA); Kirkland, (WA); Bellevue, (WA); Redmond, (WA); Stanwood, (WA) and Port Hadlock, (WA).

No other products or code dates are affected by this recall.

There have been no adverse reactions or illnesses attributed to the recalled item.

Customers who have purchased this product and are sensitive to egg products or have egg allergies should not consume the above-mentioned product. This product may be returned to the store where purchased for a full refund.

Consumers may call Patrick Quatsoe at 206-354-1921 for any further information Monday to Friday, between the hours of 8am-5pm (PST).

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