This week saw a recall on curry powder, recalls on cream cloths, recalls on wire guides, recalls on chest of drawers, recalls on croissants, recalls on football helmets, recalls on effervescent tablets, and recalls on oxacillin for injection. Details are below, courtesy of cpsc.gov and recalls.gov.
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Product Recalls for the Week of August 15, 2016:
- Curry Powder: Oriental Packing Co., Inc., is recalling approximately 377,000 lbs. of blended seasoning curry products because it is contaminated with lead. Lead can accumulate in the body over time and can cause serious and sometimes permanent adverse health consequences. A complete list of recalled products and brands can be found here. Product was distributed in New York and Florida and was sold through internet sales and retail stores nationwide. The products can be identified by the label bearing the above names in glass and plastic bottles. The sizes including 2oz, 4oz, 6oz, 8oz, 22oz and 5 lb. Product can be identified by the lot numbers and best before date listed below. This information can be found on the top of the cap or at the bottom of the bottle. Consumers are urged to dispose unused product following EPA and/or state and county regulations or return it to the place of purchase for a full refund. Recall Date: 08/12/2016
- Comfort Shield Barrier Cream Cloths (Expanded Recall): Sage Products announced today it is expanding its voluntary nationwide recall to include an additional lot of Comfort Shield Barrier Cream Cloths at the distributor and healthcare facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening. To date, no adverse events have been reported associated with the recalled products, which were distributed to distributors and healthcare facilities in the United States. The product, Comfort Shield Barrier Cream Cloths is a non-sterile, topical skin protectant used to treat and prevent moisture associated skin irritation caused by urine and/or stool exposure. The package contains single-use, disposable cloths. This recall affects the following lots of Comfort Shield Barrier Cream Cloths: Product Code 7503; NDC Number 53462-915-50; Lot Number 53957; Expiration Date 03/06/2018 and Product Code 7905; NDC Number 53462-915-80; Lot Number 55781; Expiration Date 06/19/2018. The affected lots were distributed to customers between March 31 – June 8, 2016 and July 18 – July 19, 2016. Customers who received affected products should discontinue use of the affected products and return them to Sage Products for credit by contacting Sage Products customer service. Recall Date: 08/12/2016
- Roadrunner Uniglide Hydrophilic Wire Guides: DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner® Uniglide® Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016. Cook is taking this action as a precautionary measure, because it cannot exclude the possibility that glass particles passed through during processing and could be present in the coating of the recalled wire guide units. Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system. Cook Medical has not received any reports of adverse events of these types to date. A full list of affected products and lot numbers can be found here. Products can be identified by the part number and lot number on the outer label of the package. Products in this recall were distributed globally. Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all recalled units and return the affected products to Cook as soon as possible for credit. Recall Date: 08/15/2016
- Sauder Chest of Drawers: Sauder Woodworking Co. is recalling its four-drawer chests because they are unstable unless they are properly anchored to the wall, posing a serious tip-over and entrapment hazard that could result in death or serious injuries to children. Due to a manufacturing problem, these chests do not comply with the voluntary safety standard (ASTM F2057-14). This recall involves four-drawer wooden chests sold under the Storybook brand (model 416407). The white laminated chests have a single white wood pull on each drawer. The chests were manufactured between April 2016 and June 2016. A label with the date code in the MM/YYYY format is located on the back of the unit. Products recalled include those with the date codes 04/2016, 05/2016, and 06/2016. The chests measure 42.13 inches high by 29.25 inches wide and 16.25 inches deep. Recalled products were sold exclusively online at walmart.com from April 2016 through June 2016. Consumers should immediately stop using any recalled chests that are not properly anchored to the wall and place them in an area that children cannot access. Sauder Woodworking is contacting all known purchasers directly and sending free repair kits and wall anchoring kits. If a consumer is unable or unwilling to attach the repair kit, they should contact Sauder Woodworking for a full refund. Consumers who request a refund will be provided instructions by Sauder on how to properly dispose of the chests. Recall Date: 08/16/2016
- Bakers of Paris Croissants: Bakers of Paris is recalling plain and chocolate croissants sold in 18 Northern California Whole Foods Market stores due to an undeclared allergen. The croissants, sold individually in self-service cases and in clear plastic packs of four, are made with an egg wash which is not declared on the ingredient list. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening reactions if they consume this product. Affected products in the self-service case were labeled “Croissant” or “Chocolate Croissant.” Both carry a PLU of 481976. Details for packaged products includes Croissant 4 Pack Bakers of Paris, PLU 241593 and Chocolate Croissant 4 Pack Bakers of Paris, PLU 241595. The recalled products have “packed on” dates of 8/16/16 or earlier and “best by” dates of 8/18/16 or earlier. The products were distributed only to 18 Whole Foods Market stores in Northern California. A full list of affected stores can be found here. Customers who have purchased this product at a listed Whole Foods Market store should discard it and may bring in their receipt for a full refund. Recall Date: 08/16/2016
- Xenith Football Helmets: Xenith LLC is recalling its football helmets because the shells of the football helmets can crack, posing a risk of head injuries to football players. This recall involves Xenith Epic Varsity, X2 Varsity, X2E Varsity and Youth football helmets with a gloss or metallic-painted polycarbonate shell sold or factory-reconditioned between May 1, 2015 and March 18, 2016. The helmets were sold in multiple sizes depending on the model, and in varying colors and custom-paint designs. They have a facemask and a chin cup, available in different styles and varying colors, and may have an optional eye shield. The serial number is printed on a white sticker inside the top of the helmet. A complete list of the serial numbers included in this recall is available at www.xenith.com/recall. Recalled football helmets were sold through team dealers and direct school sales, and at BSN, Buddy’s All Stars, Carey’s Sporting Goods, End Zone Sports and Sports, Inc. and other stores nationwide and online at Eastbay.com, Footlocker.com, SafetyFirstSports.com, SportsUnlimitedInc.com and Xenith.com from May 2015 through March 2016. Football players should immediately stop using the recalled helmets. Players, coaches and parents should contact Xenith to receive a free new replacement helmet. Recall Date: 08/17/2016
- Cetylev Effervescent Tablets: Arbor Pharmaceuticals, LLC (Arbor) today announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. This results in enlarged and swelled tablets which could also completely dissolve within the blister pack. Three lots of the 500 mg strength (Lot Numbers 005C16, 006C16 and 007C16, expiration date 02/2018) with NDC 24338-700-10 are included in the recall. Healthcare facilities should immediately discontinue use from these lots of product and return all unused Cetylev to Arbor. To date, Arbor has not received any reports of adverse events related to this recall. Product was distributed nationwide to wholesalers and pharmacies. Consumers with questions regarding this recall should contact Arbor Pharmaceuticals, LLC. Recall Date: 08/18/2016
- Oxacillin for Injection: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent has initiated this voluntary recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide. In the event that metal particulate in an injectable product is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, or blockage of blood vessels. Blockage of blood vessels can lead to serious events, which may be life-threatening, such as stroke, heart attack, respiratory failure, kidney failure, or liver failure. The product is packaged in cartons containing 10 x 10 gram Pharmacy Bulk Package bottles identified by NDC 25021-163-99. The lot number being recalled is Lot OXT512 which was distributed to hospitals, wholesalers and distributors nationwide from June 2016 through July 2016. Oxacillin for Injection, USP, 10 g is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. It is available by prescription only. Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for the return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lot of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com. Recall Date: 08/18/2016
