Category Archives: Food and Drug Administration

Exceptional Health Products Issues Allergy Alert On Undeclared Soy And Milk Allergens In Angel Wings™- Daily Multi 120 Capsules

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ucm497171Exceptional Health Products of Tulsa Oklahoma is recalling Angel Wings™ – Daily Multi 120 Capsules because this product contains undeclared SOY and MILK allergens. People who have an allergy or severe sensitivity to Soy or Milk allergens run the risk of serious or life-threatening allergic reaction if they consume this product.

The following product was distributed nationwide to consumers through mailorder.

Product Name: Angel Wings™ – Daily Multi 120 Capsules

Lot Numbers: 14656, 14657, 15109, 15489, 15488, 15616, and 16007

This voluntary recall has been initiated because this product contains undeclared SOY and MILK allergens. People who have an allergy or severe sensitivity to Soy or Milk allergens run the risk of serious or life-threatening allergic reaction if they consume this product.

No illnesses have been reported to date. This was brought to our attention by the Food and Drug Administration that found inconsistencies with our supplier’s allergen statement on the Amino Acid ingredients used in this formulation.

The recalled lot numbers began shipping nationwide on December 23, 2014. If you find the recalled lot numbers on the bottom of any bottle you have inventory you may return it to the address at the bottom for a full refund or replacement. If you have further distributed this product, please identify the recipients or your customers and notify them at once of this product recall.

If you have any questions, call 888-548-0477 Monday thru Friday 8:00 AM to 5:00 PM CST. We are sorry for this inconvience and appreciate your assistance.

Voluntary Recall of Fetch™ 2 Aspiration Catheter

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MARLBOROUGH, Mass. – Boston Scientific (NYSE: BSX) has initiated a global, voluntary recall of all models of its Fetch™ 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage. The U.S. Food and Drug Administration (FDA) classified the action as a Class 1 recall. This recall designation means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.

There have been no reports of patient injury or death, and there is no risk to patients who previously underwent a thrombectomy procedure with the Fetch 2 catheter. All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications. While unreported, the most severe potential outcome of this breakage is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically.

As part of the recall, all affected healthcare facilities were advised to discontinue use of all Fetch 2 catheters immediately and return unused product to Boston Scientific. Because Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care Inc., all recalled inventory is packaged and labeled as Bayer product. This device was manufactured between June 11, 2014 and February 19, 2016. There are currently 21,155 devices on the market subject to this recall.

Fetch 2 Catheter UPNs
FETCH2 US
109400-001
FETCH2 OUS
109400-002
FETCH2 Canada
109400-003
FETCH2 Japan
109400-004
FETCH2 EU
109400-005

Physicians and healthcare facilities can direct questions to their Boston Scientific representative or, call 1-800-811-3211. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
    or
  • Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to Boston Scientific by calling 1-800-811-3211 and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Vascular Solutions, Inc. Issues Recall of Guardian® II Hemostasis Valves

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On March 3, 2016, Vascular Solutions, Inc. (Nasdaq: VASC), initiated a nationwide recall of Guardian II hemostasis valves used in catheterization procedures. Specific lots of the products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. This recall only affects the Guardian II hemostasis valves and does not include the Guardian II NC hemostasis valves. No injuries have been reported in association with this issue to date.

Healthcare facilities that have the affected Guardian II hemostasis valves should remove the products from their inventory and return them to Vascular Solutions.

The recalled products were manufactured from March 2015 to February 2016 and distributed from April 2015 to February 2016.

The recalled products are specific lots of Model Numbers 8210 and 8211. A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products. A total of 26,550 devices have been manufactured, with 5,283 distributed in the United States. The condition that led to the recall may affect approximately 2.4% of recalled devices.

Vascular Solutions Inc. voluntarily initiated the recall on March 3, 2016 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. The notification identified the specific lots subject to the recall and included instructions on how to return the affected products.

The U.S. Food and Drug Administration (FDA) classified this as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at customerservice@vasc.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program:

For further information, connect to www.vasc.com.

Progressive Gourment Inc. Issues an Allergy Alert on Taste of Inspirations Edamame Rangoon

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ucm495082Progressive Gourmet Inc. of Wilmington, MA, is voluntarily recalling its frozen, 9 ounce packages of Taste of Inspirations Edamame Rangoon out of an abundance of caution because they have the potential to contain crustacean shellfish (crab). People who have an allergy to crustacean shellfish run the risk of serious or life-threatening allergic reaction if they consume these products. The item is produced for Hannaford Supermarkets.

The product comes in a 9 ounce carton, marked with Best Before: 1 1117 on the back of the retail carton. Note, no other production runs of this product are impacted by this recall.

The potentially impacted Edamame Rangoon were possibly sold to consumers at select Hannaford stores located in Maine, Massachusetts, New Hampshire, Vermont and New York.

A consumer reported the mislabeling incident. The firm has initiated prompt corrective actions to prevent future mislabeling. No illnesses have been reported to date in connection with this product.

Consumers who have purchased 9 ounce packages of the edamame rangoon are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-224-7630 (9:00 am – 5:00 pm Monday through Friday EST).

Pilgrim’s Pride Corp. Recalls Poultry Products Due To Possible Foreign Matter Contamination

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

WASHINGTON — Pilgrim’s Pride Corp., a Waco, Texas establishment, is recalling approximately 40,780 pounds of fully cooked chicken nugget products that may be contaminated with extraneous plastic materials, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The fully cooked chicken nugget products were produced on Oct. 5, 2015. The following products are subject to recall: [Label (PDF Only)]

20-lb. cardboard boxes containing two, 10-lb. clear plastic bags of fully cooked chicken nuggets labeled as “GOLD KIST FARMS Fully Cooked Whole Grain Popcorn Style Chicken Patty Fritters.”

The products subject to recall bear establishment number “EST. P-20728” inside the USDA mark of inspection and include package codes 5278105021, 5278105022, 5278105023, 5278105000, and 5278105001. These items were shipped for institutional use to Arizona, California, Colorado, Florida, Georgia, Kansas, Kentucky, North Carolina, Nebraska, Oklahoma, Tennessee, Texas, and Utah.

The problem was discovered after the firm received several consumer complaints regarding plastic contamination of the chicken nuggets. The firm notified FSIS personnel of the issue on April 6, 2016.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Namias of Arizona Recalls Chicken Products Due To Misbranding and Undeclared Allergens

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Namias of Arizona, Inc., a Tucson, Ariz. establishment, is recalling approximately 19,200 pounds of chicken 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 contain hydrolyzed soy protein, a known allergen which is not declared on the product label.

The fully-cooked chicken items were produced on various dates between Sept. 2, 2015, and March 1, 2016. The following products are subject to recall:

  • 20-pound cases containing 5-pound bags of “Carlotta’s Kitchen CHICKEN CHILE VERDE.”
  • 20-pound cases containing 5-pound bags of “Carlotta’s Kitchen SPORTS CHICKEN,” a chili-type entree.

The products subject to recall bear establishment number “P-6006” inside the USDA mark of inspection. The chicken chile verde items were shipped to the company’s restaurant in Nevada. The sports chicken items were shipped to the company’s restaurants in Arizona.

The problem was discovered by FSIS personnel during a routine label review at the establishment. Hydrolyzed soy is a component of the chicken base used to manufacture the products.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

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 Garret Boos, company operations manager, at (520) 903-1922.

McCain Foods USA, Inc. Recalls Pork Products Due To Possible Foreign Matter Contamination

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McCain Foods USA, Inc., a Lisle, Ill. establishment, is recalling approximately 25,215 pounds of bacon fritters that may be contaminated with extraneous plastic materials, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The potato, egg, cheese, and bacon fritters were produced on Nov. 11, 2015. The following products are subject to recall:

1,681 cases bearing a batch code 1001487402 containing four 3.75-lb. plastic vacuum-packed packages containing “McCain EARLY RISERS Potato, Egg, Cheese & Bacon Fritters.”

The products subject to recall bear establishment number “EST. 18846” inside the USDA mark of inspection. These items were shipped to food service distributors in Arkansas, Florida, Iowa, Indiana, Illinois, Kansas, Maine, Oklahoma, Ohio, Texas, Tennessee, and Utah.

The problem was discovered after the firm received a consumer complaint and subsequently notified an in-plant FSIS inspector.

There have been no confirmed reports of adverse reactions due to consumption of these products. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Medical advisory on St. Jude Optisure dual coil defibrillation leads for implantable cardioverter defibrillators

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St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that a previously communicated voluntary global field safety action related to the company’s Optisure™ Dual Coil Defibrillation Leads has now been classified as a Class 1 Advisory by the U.S. Food and Drug Administration. The Class 1 Advisory relates to a limited and well-defined group of 447 Optisure leads, 278 of which were distributed in the U.S., which may have been damaged during a manufacturing step. The company has received no reports of lead malfunction or patient injury related to this issue and all physicians with patients impacted by this advisory have been notified.

Optisure dual coil defibrillation leads are used in conjunction with implantable cardioverter defibrillators (ICDs), which monitor the heartbeat of patients suffering from heart rhythm disorders. An ICD’s leads deliver electric current to the heart to help restore the heart to its normal rhythm when needed.

On November 3, 2015, St. Jude Medical began the global process of notifying physicians following patients who have been implanted with the 447 Optisure dual coil leads subject to this advisory. An investigation revealed a variation in the process to remove excess medical adhesive used in the assembly of the superior vena cava (SVC) shock coil in a limited and well-defined group of Optisure leads could result in cuts to the insulation of the lead. Depending on device programming and the depth of the inadvertent cut to the insulation, compromise of lead insulation can potentially lead to an electrical malfunction wherein the defibrillator cannot deliver appropriate high voltage therapy.

A St. Jude Medical internal investigation found the probability that a lead was damaged as a result of the manufacturing variation to an extent that it could result in the inability to deliver appropriate high voltage therapy is very low and that any associated risks can be prevented with device reprogramming. The patients’ leads can also be monitored from home using the Merlin.net™ remote care system. The company has not received any reports of compromised performance of the impacted Optisure leads. St. Jude Medical is in the process of providing an updated advisory notice to physicians to further ensure physicians are aware of recommendations for managing their patients who may have been implanted with the impacted leads.

The advisory notification involves the worldwide distribution of 447 Optisure dual coil defibrillation leads manufactured and distributed by St. Jude Medical. The advisory relates to units within the following models: LDA220, LDA220Q, LDA230Q, and LDP220Q.

The vast majority of patients implanted with the Optisure leads compromised by the advisory have devices equipped with the St. Jude Medical DynamicTx™ feature that provides additional protection to help ensure delivery of appropriate high voltage therapy even in the case of a compromised lead. For these patients, physicians are advised to enroll patients in the Merlin.net patient care network, ensure the DynamicTx feature is programmed “on” and then monitor patients as per normal follow-up protocols.

Physicians following the 9 patients in the U.S. with compromised leads not connected to a device with the DynamicTx feature have been advised to enroll these patients in the Merlin.net patient care network and, where appropriate, consider turning off the SVC coil. If a dual coil shocking configuration is desired, physicians should consider performing a high voltage test when clinically appropriate to determine whether the lead has been compromised. As of this letter all physicians following the 9 patients have been contacted and provided information about this event.

Patient safety is St. Jude Medical’s highest priority, and the company will continue to work closely with customers and global regulatory agencies to ensure effective communication to our physician partners. The company has alerted all physician customers impacted by the advisory by letter, and all leads subject to this advisory have been accounted for and none remain in any field distribution. The U.S. Food and Drug Administration and other regulatory bodies have been notified. For more information, patients or their physicians can visit www.sjm.com/optisureadvisorydisclaimer icon or call the St. Jude Medical customer service team 24 hours a day at (800) 328-9634.

Berks Packing Co. Recalls Beef Products Due to Misbranding

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Berks Packing Co., a Reading, Pa. establishment, is recalling approximately 1,320 pounds of beef products that may be misbranded, and may contain pork and erythorbate, an additive, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The beef knockwurst links were produced on Nov. 12, 2015.
Berks-2

Berks-1
>> 1-lb. (plastic shrink wrapped) packages containing links of “BERKS Heat & Serve Knockwurst.” The packages have a sell by date of March 11, 2016 printed on the package.

The products subject to recall bear establishment number “EST. 8782” inside the USDA mark of inspection. These items were shipped to retail locations in Pennsylvania, New Jersey, Maryland, New York, West Virginia, Virginia, and Delaware.

The problem was discovered by company personnel who learned of the incorrect labels being applied to the product and notified FSIS inspectors.

There have been no confirmed reports of adverse reactions due to consumption of these products. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Abbott’s Compounding Pharmacy Issues Voluntary Recall of All Lots of Unexpired Sterile Human and Animal Compounded Products Due to Lack of Sterility Assurance

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Abbott’s Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California.

All recalled products have a label that includes the Abbott’s Compounding Pharmacy name and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date. This recall impacts all sterile products distributed between 01/01/2015 and 01/14/2016.

The recall was issued after a series of onsite inspections by the FDA. Out of an abundance of caution, Abbott’s Compounding Pharmacy is voluntarily recalling all sterile compounded products within expiry. If there is microbial contamination in products intended to be sterile, patients are at risk for serious and potentially life-threatening infections.

To date, Abbott’s Compounding Pharmacy has not received any reports of any adverse effects or injuries, and the recalled products were distributed exclusively within the state of California directly from its Berkeley, California pharmacy location.

Customers that have recalled product should immediately stop using it and contact the pharmacy to arrange for the return of unused product. Customers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products.

Customers with questions regarding this recall can contact Abbott’s Compounding Pharmacy by phone Monday thru Friday, 9:00am to 5:00pm at (510) 548-8777, or email its media representative.

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.

  1. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  2. Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
  3. For reporting animal adverse drug events: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

Abbott’s Compounding Pharmacy deeply regrets any disruption that this voluntary recall and temporary suspension of Sterile compounding services have on its Customers, but notes that safety and quality are its primary concerns.