Tag Archives: 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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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

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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California Olive And Vine Announces The Voluntary Recall Of Pumpkin Seed Pesto

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California Olive and Vine, LLC of Sutter, CA is taking precautionary measures and voluntarily recalling Pumpkin Seed Pesto because of irregular lab results. The company found that the jarred pesto may have been improperly processed, making it susceptible to contamination with Clostridium botulinum.

This food product was distributed under the Williams-Sonoma label, nationwide, since September 2014. The product labels have the following SKU numbers 6404305, 6389043 and is sold in an 8 ounce glass jar, as pictured below. The company has made the deliberate decision to recall this product to ensure the safety of their customers. The company has not been notified of any illness associated with this product.

No other products from this company are affected.

Ingestion of botulism toxin may lead to serious illness and death. To date, there have been no reports of any illnesses or contamination of the product.

Symptoms from Botulism are as follows: general weakness, dizziness, double vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distention and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

Consumers are warned not to use the product even if it does not look or smell spoiled.

California Olive and Vine immediately segregated its entire inventory of this product and has notified Williams-Sonoma and CDPH directly. Consumers who have purchased the recalled Pumpkin Seed Pesto are urged to dispose of the product or return it to the place of purchase for a refund. Consumers with questions may contact the company Monday through Friday between 10am and 4pm.pesto

California Firm Expands Recall of Beef Products Due To Possible Processing Flaw

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640-galinasWASHINGTON – Galant Food Company, a San Leandro, Calif. establishment, is recalling an additional 130 pounds of beef products because the meat filling used in the products did not meet its cooking critical limit, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The additional products subject to the recall include: [Labels (PDF Only)]

  • 6.5-oz. Paramount Beef and Cheese Piroshki, 12 per case, with case codes 092214
  • 7-oz. Galinas Original Beef and Cheese Piroshki, 12 per case, with case codes 092314

The products, which bear the establishment number “EST. 9014,” were produced Sept. 22 through 23, 2014 and then shipped to a distributor in the San Francisco Bay area.

The problem was discovered by the company when visiting its distributor and identifying that the products, as those in the initial recall, contained the same filling that did not reach lethality.

FSIS and the company have received no reports of adverse illnesses due to consumption of these products. Anyone concerned about an 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.

This is a Class I recall which means a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

Allergy Alert On Undelcared Eggs In Lotte Waffles

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ucm418337LOTTE Confectionery Co., Ltd. (manufacturer), 21-5ka, Yangpyung-dong, Youngdeunpo-gu, Seoul, Korea, is recalling its 1.41 ounce (40g) and 5.64 ounce (160g) packages of Lotte Waffles because they contain undeclared egg ingredients. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

(Product Barcode: 1.41 ounce – 8 801062 518111 / 5.64 ounce – 8 801062 518135)

The recalled Lotte Waffles were distributed to California, Nevada, Arizona, New Mexico, Washington, Texas, Oklahoma, Illinois, New Jersey, Maryland, and Canada retail stores.

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HAR Maspeth Corp recalls Jinga brand “Pan Fried Anchovies” Because of possible health risk

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HAR Maspeth Corp. of Maspeth, NY, is recalling its 2 ounce and 4 ounce packages of Jinga “Pan Fried Anchovies” due to contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Although healthy persons may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The recalled Jinga “Pan Fried Anchovies” were distributed nationwide in retail stores and through mail orders. The product comes in a 2 ounce and 4 ounce, clear plastic packages marked with an expiration date of “9/28/2014” stamped on the top.

An alleged illness has been reported to date in connection with this problem.

The recall was initiated after routine sampling by The Virginia Department of Agriculture and Consumer Services Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the presence of Listeria monocytogenes.

J&B European Distribution Inc. Issues Allergy Alert For Undeclared Milk In Kupiec Rice Cakes With Dark Chocolate

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J&B EUROPEAN DISTRIBUTION INC. of BROOKLYN, NY is recalling 40 cases of KUPIEC brand RICE CAKES WITH DARK CHOCOLATE, NET WT. 3.1 OZ. (90g), UPC # 5 906747 171742, because they may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

KUPIEC brand RICE CAKES WITH DARK CHOCOLATE, NET WT. 3.1 oz. (90g) were distributed to retail outlets throughout NY, NJ, and PA, and to one retail location in North Carolina. The product was shipped between 6/24/2014 and 7/23/2014.

KUPIEC brand RICE CAKES WITH DARK CHOCOLATE, NET WT. 3.1 oz., UPC # 5 906747 171742, are packed in a white oval plastic package picturing a stack of the rice cakes topped with chocolate. There are 6 rice cakes per package. The product was imported from Poland.

J&B EUROPEAN DISTRIBUTION is not aware of any confirmed illnesses to date in its distribution area; however the FDA has confirmed one such case in the Chicago, IL area.

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

Consumers who have purchased KUPIEC brand RICE CAKES WITH DARK CHOCOLATE, NET WT. 3.1 oz., UPC # 5 906747 171742, are urged to return it to the place of purchase for a full refund. Consumers with questions may contact J&B EUROPEAN DISTRIBUTION at 1-718-782-3712, Monday – Friday, 8am – 4pm, ET.