Category Archives: Food and Drug Administration

Recall of Northstar Label Gabapentin Capsules

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ucm424493Dayton, NJ, Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.

Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening. Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall to date, but has received four complaints for empty capsules.

Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. The product can be identified by the imprint D on yellow cap and 03 on yellow body with black edible ink. Product was distributed through Northstar label to retail outlets nationwide.

Aurobindo Pharma USA, Inc. is notifying its distributors and customers by recall letters and is arranging for return of all recalled product. Consumers, distributors, and retailers that have product which is being recalled should stop using, distributing, or dispensing the affected lot and return to place of purchase.

Consumers with questions regarding this recall can contact Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400 Option 2 or PVG@aurobindousa.com Monday through Friday, 8:30AM to 5:00PM EST. 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.

Great American Appetizers, Inc. Recalls Hyvee Mozzarella Cheese Sticks Due To Undeclared Soy Flour, Yellow #5, And Yellow #6

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640px-ucm423215Great American Appetizers, Inc. of Nampa, Idaho is recalling 662 cases of HyVee Mozzarella Cheese Sticks because they may contain undeclared soy flour, yellow #5 and yellow #6. People who have an allergy or sensitivity to soy, yellow #5 or yellow #6 can run the risk of serious allergic reaction if they consume this product.

The HyVee Mozzarella Sticks were distributed to retailers in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin.

The HyVee Mozzarella Cheese Sticks affected are in an 8 oz. (227 g) carton (UPC #075450149913). The product date codes are printed on the end of the carton: 14290402 (BEST IF USED BY 4/17/2016) and 14295402 (BEST IF USED BY 4/22/2016). No other date codes are affected by this recall.

No illnesses have been reported to date.

This incident was discovered in-house by the company’s internal packaging review. Great American Appetizers, Inc. staff determined that the new carton did not accurately describe all allergens present in the product during the packaging update.

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

Consumers who have purchased HyVee Mozzarella Cheese Sticks may return them to the place of purchase for a full refund. Consumers with questions may contact the company at: 1-800-282-4834 from 8AM – 5PM Mountain Time, or email inquiries to KalaT@appetizer.com.

Hawaii Firm Recalls Frozen Pork Products Due To Misbranding and Undeclared Allergen

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WASHINGTON – Kulana Foods Ltd., a Hilo, Hawaii establishment is recalling approximately 4,465 pounds of frozen, fully cooked pork products because of misbranding and an undeclared allergen. The products are formulated with a soy sauce that contains wheat, a known allergen, which is not declared on the label.

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

The products subject to recall include:

  • Various weight (approximately .75 – .90 lb.) packages of “MOUNTAIN APPLE BRAND Teri Smoked Pork” with identifying case codes: 03414, 07214, 12814, 16914, 21114, 28114, 03713, 05113, 06513, 23313, or 34513.
  • 5-pound packages of “MOUNTAIN APPLE BRAND Teri Smoked Pork” with identifying case code: 09214.

The products bear the establishment number “EST. 12445” inside the USDA mark of inspection on the label. The products were produced on various dates between Feb. 6, 2013 and Oct. 8, 2014 and shipped to retail locations and for foodservice use on the islands of Hawaii and Oahu.

The problem was discovered by FSIS personnel during a label review at the establishment. FSIS personnel are responsible for verifying that establishments are actively labeling the eight most common food allergens. Wheat was a sub-ingredient of soy sauce used in the product and was inadvertently left off the product label.

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.

Marin Food Specialties, Inc. Initiates Voluntary Recall of Imported Organic Raw Almonds (Bitter Almonds)

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Due to Elevated Levels of Naturally Occurring Hydrogen Cyanide
raw-almonds
Marin Foods Specialties, Inc. of Byron, CA is voluntarily recalling Organic Raw Almonds (bitter almonds), due to them possibly containing elevated levels of naturally occurring hydrogen cyanide according to laboratory test results. To date, no human illnesses have been associated with these products and they have been pulled from sale.

Bitter almonds are the wild form of the edible “sweet almonds.” Bitter almonds contain a chemical called glycoside amygdalin, which becomes transformed into toxic prussic acid (hydrogen cyanide) after they are crushed or chewed. Eating foods that contain prussic acid may result in some or all of the following signs and clinical symptoms within minutes: dizziness, headache, nausea and vomiting, rapid breathing, rapid heart rate, restlessness, and weakness. Exposure to higher quantities of food containing prussic acid may cause other more serious health effects including convulsions, loss of consciousness, low blood pressure, lung injury, slow heart rate, and respiratory failure leading to death. Showing these signs and symptoms does not necessarily mean that a person has been exposed to cyanide. Treatment with supportive measures and available specific and efficacious antidotes frequently allows survival.

The products were labeled as “Whole Foods Market Organic Raw Almonds Imported from Italy” and “Whole Foods Market Organic Raw Almonds Imported from Spain,” and were packaged in 13.5 oz. plastic tubs. The recalled products have sell-by dates from 4/18/15 to 6/7/15 and a UPC code of UPC 9-99482-00071-7. The recalled product was distributed to Whole Foods Market stores only in Northern California, Oregon, Washington, Reno, Nevada and Boise, Idaho.

Bartlett Milling Company Issues Recall of Horse Food

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Bartlett Milling Company has initiated a limited recall of certain horse feeds due to potential Rumensin contamination. The products were distributed to customers and retailers in North Carolina, South Carolina, Tennessee and Virginia.

Rumensin contamination can result in health problems, including mortality, in horses. The products and lot number involved in the recall are:

  • 50 lb. bags of Bartlett Pasture Horse 10 Feed – Lot 288
  • 50 lb. bags of Cleveland Carolina Champion Horse Feed – Lot 288

The recalled products were packaged in typical brand-specific feed bags. Lot numbers are printed on the front and back of each bag.

Retailers have been contacted and instructed to immediately withdraw from sale the recalled product and to notify customers who purchased the product. Customers should discontinue feeding the product immediately. Customers who purchased this product should return remaining bags to their retailer.

For more information on the product recall, contact Bartlett Milling at 1-800-438-6016 from 8AM to 5PM Monday through Friday. Contact Bartlett at 1-336-655-1840 outside of regular business hours.

This recall is being conducted with the knowledge of the North Carolina Department of Agriculture & Consumer Services and the United States Food and Drug Administration.

Whole Foods Market Melrose Recalls Vegan Gingersnap Cookies Due to Mislabeling and Undeclared Allergens

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ucm420686Cambridge, MA – Whole Foods Market is recalling “Vegan Gingersnap Cookies” produced and sold only in the Melrose, Massachusetts location due to a labeling error that resulted in undeclared tree nut, milk, soy and egg allergens. The product has a “Sell By” date of October 28, 2014.

The six-packs of cookies labeled as “Vegan Gingersnap Cookies” contained tree nuts (walnut and almond), milk, soy and egg, known allergens, which are not declared on the label. People who have an allergy or severe sensitivity to those ingredients run the risk of serious or life-threatening allergic reaction if they consume these products.

The cookies were sold in the store between October 23 and October 26, 2014.

Signage is posted to notify customers of this recall, and all affected product has been removed from shelves.

No allergic reactions or illnesses have been reported.

Consumers who have purchased this product from Whole Foods Market Melrose may bring their receipt to the store for a full refund. Consumers with questions should contact their local store or call 617-492-5500 between the hours of 9am and 5pm EST.

Nutek Disposables, Inc. Issues Alert Due to Potential Bacteria in Baby Wipes

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300-Baby-Wipes1

FDA Photo. Sample Only. See Table.

MCELHATTAN, PA — Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred’s, Kidgets, Member’s Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria. These wipes were distributed by Nutek prior to October 21, 2014 to the following retail stores: Walgreens, Sam’s Club, Family Dollar, Fred’s, and Diapers.com.

After receiving a small number of complaints of odor and discoloration, Nutek conducted microbial testing that showed the presence of a bacteria, called Burkholderia cepacia (B. cepacia), in some of these products. Soon after, on October 3, 2014 the company initiated a voluntary withdrawal of lots that had tested positive for the bacteria, as well as other baby wipes in the surrounding time frame. After some additional lots were tested, as a precautionary measure, Nutek believed it was a prudent decision to withdraw all its baby wipe products.

B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. If you believe you have a weakened immune system or chronic lung disease and you have used one of the affected wipe products, you should call your doctor promptly for medical advice.

As of October 3, 2014, the date of the original withdrawal, the company had received only one report of irritation. Numerous reports of complaints have since been received by the company that include rash, irritation, infections, fever, gastro-intestinal issues, and respiratory issues, though these reports have not been confirmed to be related to the use of these products.

The company has not identified the cause of the problem, but is continuing to investigate. In the interim, Nutek has stopped shipping baby wipes manufactured at the facility.

Nutek takes the safety of consumers and the quality of its products very seriously and is taking all appropriate steps to address the issue and ensure this does not happen again.

The company is working with the U.S. Food & Drug Administration and the affected retailers and distributors throughout this process to address the issue.
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Brand Name Retailer Lot Numbers of Product Manufactured by Nutek
Cuties Internet and various retailers All Lots
Diapers.com Diapers.com All Lots
Femtex Family Dollar All Lots
Fred’s Fred’s All Lots
Kidgets Family Dollar All Lots
Member’s Mark Sam’s Club All Lots
Simply Right Sam’s Club All Lots
Sunny Smiles Walgreens All Lots
Tender Touch Various retailers All Lots
Well Beginnings* Walgreens Certain Lots±
*These lot numbers represent all lots manufactured by Nutek. There may be other lots that are made by manufacturers other than Nutek and that are not subject to this recall.

Lundberg Family Farms Recalls Sea Salt Rice Chips Due to Undeclared Allergen

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200pxfda-rice-chipsRICHVALE, Calif. — Lundberg Family Farms announced that it is voluntarily recalling from distribution in the United States and Canada, specific bags of Sea Salt Rice Chips due to possible presence of an undeclared dairy allergen. The issue was discovered through a consumer complaint.

The recall applies to only 6 ounce bags (170g) of Sea Salt Rice Chips packed on August 11th, 2014, bearing the code “140811” and a best before date of “2015 JUN 08” on the upper right-hand corner of the bag. The Sea Salt Rice Chips display the following UPC numbers 0-73416-03530-0 for U.S., or 0-73416-03540-9 for Canada.

Lundberg Family Farms has identified the problem and has taken immediate corrective action. Distributors and retailers have been notified and requested to discard the affected products in stock. The company notified the U.S. Food and Drug Administration, and is cooperating fully with the agency.

No serious injuries or illness have been reported from the consumption of the product. People who have a severe allergy to dairy run the risk of serious or life-threatening allergic reaction if they consume this product.

Customers who have bags of Sea Salt Rice Chips with the aforementioned labeling should discard them or return them unopened to the place of purchase for a refund. Customers can call our customer service representatives at 530-538-3555, which is staffed seven days a week, 8:30 a.m. to 5 p.m. Pacific Time, or leave a message at other times, with any questions or concerns about the product, or email recall@lundberg.com.

Bailey Farms Inc. Recalls Fresh Serrano Chile Peppers Because Of Possible Health Risk

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logo-bailey-farms-editBailey Farms, Inc. of Oxford, NC is voluntarily recalling 6,215 pounds of Fresh Serrano Chile Peppers, because it has the potential to be contaminated with 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), endocarditic and arthritis.

The Fresh Serrano Chile Peppers was distributed to Meijer, Inc. and customers may have purchased this product from October 14th to October 19th at Meijer stores in Michigan, Illinois, Indiana, Kentucky and Ohio.

In addition this product was distributed to Publix Super Markets Inc., Merchants Distributors, Inc., Walmart, Food Lion, Flavor 1st Growers and Packers, US Foods, Military Produce Group, LLC.,C&S Wholesalers, John Vena, Inc. and Harris Teeter. Consumers who suspect they may have purchased Fresh Serrano Chile Peppers from the above listed companies between the dates of October 2, 2014 to October 21, 2014 should check with the above listed companies to verify if the product was subject to recall.

No illnesses have been reported to date.

A random sample was taken by the Michigan Department of Agriculture on October 13, 2014 from a warehouse in Lansing, Michigan. Bailey Farms, Inc. received notice that the sample tested positive for Salmonella on October 20, 2014. This recall is the result of the possibility that the remainder of these lots could be contaminated with this bacteria. We are working with the North Carolina Department of Agriculture and Consumer Services to investigate the root cause of the potential contamination.

Bailey Farms, Inc. has notified all of their customers who have purchased Fresh Serrano Chile Peppers during said dates.

Consumers with questions can contact Bailey Farms, Inc. M-F 8:00 am to 5:00 pm EST 1-888-820-2545.

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.