Category Archives: Food and Drug Administration

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.
ucm419326

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

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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Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon and Washington

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Wilsonville, Ore. – Oregon Compounding Centers, Inc., dba Creative Compounds, is voluntarily recalling certain unexpired human and veterinary sterile products to the consumer level due to lack of sterility assurance.

The company has not received any reports of product contamination or adverse events to date, but is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

“We are fully cooperating with health officials,” said Denise Burnham, R.Ph., owner and pharmacist. “We deeply regret the impact this voluntary recall has on our customers, but patient safety is our highest priority.”

All recalled products have a label that includes the Creative Compounds name as well as a lot number. The recalled products were made from July 1, 2014 through September 22, 2014, and distributed to health care facilities, physicians, and patients in two states, Oregon and Washington.

The recall does not pertain to any non-sterile compounded medications prepared by the pharmacy.

All unexpired lots of the following sterile compounded products are subject to the recall:

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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.