Safety Alerts for June 2, 2014
Alexion Initiates Voluntary Nationwide Recall of Certain Lots of Soliris® (eculizumab) Concentrated Solution for Intravenous Infusion Due to the Presence of Visible Particulate Matter in a Single Lot
— Alexion’s global supply chain continues to provide Soliris to commercial and clinical patients without interruption —
Irving Adler, 203-271-8210
Executive Director, Corporate Communications
Kim Diamond, 203-439-9600
Senior Director, Corporate Communications
FOR IMMEDIATE RELEASE – June 2, 2014 – Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced that it is initiating a voluntary recall of certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level. As previously stated, Alexion believes that it has identified the process component that resulted in the presence of the visible particles and implemented a change to the process. Alexion does not anticipate any interruption to patient supply. This recall has been initiated due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing for Soliris. This lot was distributed only in the U.S. No safety risks to patients who have received Soliris have been identified. There is no financial impact from the voluntary recall announced today..
The single affected Soliris lot is #10007A. Although these lots currently remain in specification, Alexion is including the following remaining lots, which were produced with the same process component during vial filling, within the scope of the U.S. recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A. Following this voluntary recall, there will no longer be Soliris in the U.S. manufactured using the previously identified process component that Alexion believes resulted in the stability failure.
The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immune reaction and blood clots. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening. To date, there have been no product complaints of particulates, or identifiable safety concerns attributed to the product consumed from the affected lots. As product from the affected lot was last shipped on Oct. 29, 2013, Alexion believes there is little, if any, inventory currently being held at the hospital or user level.
Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two ultra-rare and life-threatening disorders. Alexion and its distributors typically ship Soliris to healthcare providers in small quantities, which are timed to individual patient infusions, with the product being consumed before more is shipped. As product from the identified lots was last shipped on October 30, 2013, there is anticipated to be little, if any, material from these lots still remaining in commercial distribution.
The following table lists the lots that are being recalled, which were distributed in the U.S. to wholesalers, hospitals, and pharmacies:
||First Ship Date
||Last Ship Date
300 mg/30 mL
Concentrated solution for intravenous infusion only
||June 17, 2013
||Oct. 29, 2013
||Sept 6, 2012
||Sept 9, 2013
||Oct 12, 2012
||May 15, 2013
||Mar 28, 2013
||Oct 3, 2013
||Feb 4, 2013
||Sept 24, 2013
||May 15, 2013
||Oct 28, 2013
||Sept 23, 2013
||Sept 26, 2013
||July 8, 2013
||Oct 24, 2013
||Aug 16, 2013
||Oct 30, 2013
Alexion is notifying its distributors and customers by letter being sent via Federal Express and is arranging for replacement of all recalled products. Any person in possession of vials of Soliris from these lots should stop use and arrange for return of the product to Alexion immediately by calling 1-888-SOLIRIS (888-765-4747), Monday-Friday from 8:30am to 5:00pm Eastern Time (ET). Unaffected lot numbers can continue to be used according to the instructions for use.
Healthcare professionals and pharmacists with questions regarding this recall can contact Alexion at 1-888-765-4747, Monday-Friday from 8:30am to 5:00pm ET. Patients 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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Soliris® (eculizumab)
Soliris® (eculizumab) is a first-in-class terminal complement inhibitor developed from the laboratory through regulatory approval and commercialization by Alexion. Soliris is approved in the U.S. (2007), European Union (2007), Japan (2010) and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating, ultra-rare and life-threatening blood disorder, characterized by complement-mediated hemolysis (destruction of red blood cells). Soliris is indicated to reduce hemolysis in PNH patients. Soliris is also approved in the U.S. (2011), the European Union (2011), Japan (2013) and other countries as the first and only treatment for patients with atypical hemolytic uremic syndrome (aHUS), a debilitating, ultra-rare and life-threatening genetic disorder characterized by complement-mediated thrombotic microangiopathy, or TMA (blood clots in small vessels). The effectiveness of Soliris in aHUS is based on the effects on TMA and renal function. Soliris is not indicated for the treatment of patients with Shiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). More information, including the full prescribing information on Soliris, is available at www.soliris.net.
Important Safety Information
The U.S. product label for Soliris includes a boxed warning: “Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early [see Warnings and Precautions (5.1)]. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies. Immunize patients with a meningococcal vaccine at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection [See Warnings and Precautions (5.1) for additional guidance on the management of the risk of meningococcal infection]. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program [see Warnings and Precautions (5.2)]. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747).”
In patients with PNH, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, nasopharyngitis (runny nose), back pain and nausea. Soliris treatment of patients with PNH should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. In patients with aHUS, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia. Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Please see full prescribing information for Soliris, including boxed WARNING regarding risk of serious meningococcal infection.http://soliris.net/sites/default/files/assets/soliris_pi.pdf
Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH and aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates, including asfotase alfa, across multiple therapeutic areas. This press release and further information about Alexion can be found at: www.alexionpharma.com.
Safe Harbor Statement
This news release includes forward-looking statements relating to continued adequacy of supply of Soliris, and identification and correction of the cause of the visible particles. These statements are subject to risks, uncertainties and other factors, including risks related to continuous product inventory and supply, the uncertainties involved in manufacturing of biologic products, and whether the FDA, EMA or other international regulatory authorities decide to take corrective or disciplinary actions against Alexion, as well as the risks that are described in detail in Alexion’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2014, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to place undue reliance on these forward- looking statements. All forward-looking statements are based on information currently available to Alexion, and Alexion assumes no duty or obligation to update or revise any such forward-looking statements or any other statement in this report.
Hill’s Pet Nutrition, Inc. Voluntarily Recalls 62 Bags of “Science
Diet® Adult Small & Toy Breed™” Dry Dog Food in California,
Hawaii and Nevada Because of Potential Health Risk
FOR IMMEDIATE RELEASE – June 2, 2014 – Hill’s Pet Nutrition, Inc. of Topeka, KS is voluntarily recalling 62 bags of Science Diet® Adult Small & Toy Breed™ dry dog food as they have the potential to be contaminated with Salmonella. The suspect product, part of a single production run, was distributed to 17 veterinary clinic and pet store customers in California, Hawaii and Nevada between April 24 and May 13, 2014. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
This voluntary recall is limited to 62 15.5 lb. bags of Science Diet® Adult Small & Toy Breed™ dry dog food with the Stock-Keeping Unit (SKU) code, “Best before” date and production code shown below. This product was accidentally released, as revealed during a routine inventory reconciliation. All 17 affected customers have been contacted by Hill’s and there have been no reported illnesses related to this product to date.
||“Best Before” Date/ Production Code
|Science Diet® Adult Small & Toy Breed
||08 2015 M094
The SKU number is located on the bottom of the bag, both side panels and on the back lower right hand corner below the UPC code. As illustrated below, the “Best before” date and production code is stamped on the top, middle of each bag.
Consumers who may have purchased any of these specific 62 15.5 lb bags of Science Diet® Adult Small & Toy Breed™ dry dog food should discontinue use of the product and immediately call Hill’s Pet Nutrition at 1-800-445-5777 Monday-Friday during the hours of 7am-7pm (CT). Hill’s will arrange to collect the unused portion of the product at its own expense at a time convenient for the consumer and will provide a full refund.
This voluntary recall does not impact any Science Diet® Adult Small and Toy Breed™ products with different “best before” dates or any other Science Diet products.
Hill’s Pet Nutrition is dedicated to providing high-quality, safe products and regrets the need for this voluntary recall. For further information, please contact Hill’s Pet Nutrition, Inc. at 1-800-445-5777 Monday-Friday during the hours of 7am-7pm (CT).
About Hill’s Pet Nutrition
Hill’s Pet Nutrition Inc. manufactures Hill’s® Prescription Diet® brand pet foods, therapeutic pet foods available only through veterinarians, and Science Diet® and Ideal Balance™ brand wellness pet foods sold through veterinarians and pet specialty retailers. Founded more than 70 years ago with an unparalleled commitment to pet well-being, Hill’s’ mission is to help enrich and lengthen the special relationships between people and their pets. For more information about Hill’s, our products and our nutritional philosophy visit HillsPet.com, or visit us on Facebook, keywords “Hill’s Pet Nutrition.”
Glutino Voluntarily Recalls Glutino Rosemary and Olive Oil Snack Crackers (4.25 oz. and 20 oz.) Because of Possible Health Risk
FOR IMMEDIATE RELEASE – Paramus, NJ – June 2, 2014 – Glutino, a division of GFA Brands, Inc. based in Paramus, NJ, is voluntarily recalling Glutino Rosemary and Olive Oil Snack Crackers. The recall is being initiated because the seasoning supplier, Kerry Ingredients, recalled the seasoning blend due to possible Salmonella contamination.
Glutino Rosemary and Olive Oil Snack Crackers products with “Best By” date of October 26, 2014 are being recalled because they have the potential to be contaminated with Salmonella, an organism that 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, 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.
The recalled Glutino Rosemary and Olive Oil Snack Crackers were distributed nationally through retail and warehouse club stores. The product affected is sold in a 4.25 ounce and a 20 ounce opaque white box with a “Best By” date of October 26, 2014 stamped on the top of the box. The recall is limited to the Glutino Rosemary and Olive Oil Snack Crackers and does not extend to any other Glutino products.
The affected Glutino UPCs are:
6 78523 03861 1
6 78523 03863 5
No illnesses have been reported to date with consumption of the Glutino Rosemary and Olive Oil Snack Crackers. Customers who purchased this item are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 201-421-3970 or visit http://www.glutino.com.
Since 1983, Glutino has been a trusted pioneer and leader in the gluten free category. Glutino offers a wide variety of great-tasting, gluten free foods consumers can trust. Glutino® products are available in the US and Canada at local supermarkets, natural and organic retailers. For more information on Glutino, visit http://www.Glutino.com. Glutino is a division of GFA Brands, Inc., a Boulder Brands company.
Baptista’s Bakery Inc. Issues Voluntary Recall for LiveGfree
Rosemary and Olive Oil Multiseed Snack Crackers
FOR IMMEDIATE RELEASE – June 2, 2014 – Baptista’s Bakery, Inc. is voluntarily recalling 4,339 cases of LiveGfree Gluten Free Rosemary and Olive Oil Multiseed Crackers with a best if used by date of 11-24-14 because they contain a seasoning that is being recalled by Kerry Ingredients. Kerry Ingredients is recalling the seasoning due to possible health risks related to Salmonella contamination.
The affected products were distributed nationally:
- LiveGfree 4.25 oz Gluten Free Rosemary and Olive Oil Multiseed Crackers: Best By Date 11-24-14
Consumers who have purchased this item are urged to not eat the product, and to dispose of it or return it to the store where it was originally purchased.
No illnesses have been reported. The recall is being initiated as part of the Kerry Ingredients recall of its seasonings that contained an ingredient that tested positive for Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, 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. Baptista’s Bakery became aware of this issue when Kerry Ingredients contacted Baptista’s to inform them that Kerry may have shipped an ingredient that may be contaminated with Salmonella. Baptista’s Bakery, Inc. is working closely with FDA on this issue. “Ensuring the premium quality of our products is our highest priority,” said Tom Howe, President, Baptista’s Bakery, Inc. “We stand behind the safety and integrity of our products and are issuing this recall in order to afford maximum protection of our customers”, confirmed Laura Villarreal, Director of Quality Assurance.
Customers with questions or concerns may contact Laura Villarreal at 414-409-2123 between 8:00 am and 6 pm CST.
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