Drug Recalls
Jongu 4308 Issues Voluntary Nationwide Recall of Hydro Pineapple Burn Due to the Presence of Undeclared Sibutramine.
Houston, Texas, eBay Seller ID: jongu 4308 is voluntarily recalling all lots of Hydro Pineapple Burn to consumer level. FDA analysis has found the product to contain undeclared sibutramine. Sibutramine was an FDA approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues. The presence of sibutramine in Hydro Pineapple Burn renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to recall. To date, jongu 4308 has not receive any report of adverse events related to this recall.
Risk Statement: product containing sibutramine pose a health risk to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
This tainted product is marketed as a dietary supplement for weigh losst and is packaged in a box containing ten 20g sachets. Hydro Pineapple Burn was distributed by eBay via internet at www.ebay.comExternal Link Disclaimer nationwide in the USA (from 05/29/2021 to 07/27/2021). On August 03, 2021, FDA issued a press release that warned consumers to avoid certain products found eBay, Amazon, and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to Microbial Contamination
SterRx, LLC today announced the voluntary nationwide recall of three lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL due to waterborne microbial contamination. SterRx, LLC has initiated this voluntary recall of Sodium Bicarbonate injection, to the Hospital Pharmacy level.
Intravenous administration of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL, intended to be sterile that is not sterile, could result in site specific infections as well as serious systemic infections which may be life-threatening. To date, SterRx has not received reports of any adverse events associated with this issue.
KVK Tech Inc., Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5mL Due to Temperature Abuse
KVK Tech, Inc., is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mLto the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment.
Exposure of Atovaquone Oral Suspension to extremely low temperatures, during shipment (the product is required to be protected from freezing temperatures), may result in changes to the effectiveness, appearance, taste and thickness of the liquid. Severely immunocompromised patients who receive less effective Atovaquone Oral Suspension may experience inadequate treatment of serious and life-threatening infections. To date, KVK Tech is not aware of any adverse events associated with this problem.
Food & Beverage Recalls
Frito-Lay Issues Limited Voluntary Recall on Undeclared Milk in Wavy Lay’s Original Potato Chips Distributed in North Carolina, South Carolina and Virginia
Frito-Lay today issued a voluntary recall of a limited number – 31 bags – of 7 3/4 oz. Wavy Lay’s Original Potato Chips as they may contain undeclared milk ingredients. The recall is the result of an investigation following a consumer contact. Those with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume product contained inside the recalled bags.
The products were distributed to certain retail stores in North Carolina, South Carolina and Virginia, and consumers would have been able to purchase them as early as July 23, 2021.
Ballreich Snack Food Company Recalls Bar-B-Q Seasoned Potato Chips Because of Possible Health Risk
Ballreich Snack Food Co. Tiffin, Ohio, is recalling its 1.5oz, 2.75oz, and 7oz packages of BAR-B-Q Potato Chips due to a potential contamination 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), endocarditis and arthritis.
The recalled BAR-B-Q seasoned Potato Chips were distributed regional at retails and convenience stores within Northwest, Northeast, Southwest, and Central Ohio and around Southern, MI, and Northeast, Indiana.
The product is sold in a 1.5oz, 2.75oz, and 7oz bags, and clearly marked with a “Sell by Date” of the following, printed on the front of the bag.
- 10/18/21
- 10/25/21
- 11/01/21
Able Groupe Recalling Products Labeled as Infant Formula Formulas Have Insufficient Iron Levels as Per Requirements for Infant Formula in The U.S., and Products Do Not Meet Other FDA Requirements
Able Groupe announced today it is recalling certain products used as infant formulas.
The recalled products are infant formulas (i.e., products intended as a complete or partial substitute for human milk for children 12 months old and younger), but the required pre-market notifications for these new infant formulas have not been submitted to the FDA. In addition, the HiPP Comfort Milk Formula, HiPP Dutch Stage 1 Combiotic Infant Milk Formula, HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula, HiPP German Stage 1 Combiotic Infant Milk Formula, Holle Bio Stage 1 Organic Infant Milk Formula, Holle Bio Stage PRE Organic Infant Milk Formula, Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula, and HiPP UK Stage 1 Combiotic First Infant Milk Formula products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, those who had low iron levels at birth, or those who are at risk for becoming iron deficient due to illness. Inadequate intake of iron during infancy may lead to iron deficiency anemia, which, if untreated, has irreversible cognitive and functional development outcomes. Infant formula products that contain less than 1 milligram of iron per 100 Calories are required to include a statement on the label indicating that additional iron may be necessary. These 8 infant formula product labels do not include the required statement. Furthermore, all of the infant formulas distributed by Able Group are not labeled as required by 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English.
The products were imported from Europe and distributed to consumers in the U.S. via mail services. The products were purchased through the littlebundle website (www.littlebundle.comExternal Link Disclaimer). The products were not available at any retail store. The company began distributing the products on May 20, 2021. Approximately 76,000 units were distributed.
DSD Merchandisers, Inc. Issues Allergy Alert on Undeclared Peanuts in Dark Chocolate Malt Balls 9oz Tub
DSD Merchandisers, Inc. of Livermore, CA is recalling 252 individual 9 oz. Deli tubs of Dark Chocolate Malt Balls because it may contain undeclared Peanuts. People who have an allergy or severe sensitivity to Peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Dark Chocolate Malt Balls 9oz. was distributed in Northern and Central California and Hawaii through purchases at grocery stores.
Dark Chocolate Malt Balls 9oz. is sold in plastic deli style tubs. Label states Distributed by DSD Merchandisers, Inc. UPC 651433701790 with a "Best Before" date of 3/1/2022. This is the only date code in question.
Je Dois L’avoir Boutique Issues Voluntary Nationwide Recall of 365 Skinny High Intensity and 365 Skinny Emergency Boutique Due to the Presence of Sibutramine
Hanford, California, Je Dois L’avoir Boutique is voluntarily recalling all of the 365 Skinny High Intensity Pills and or 365 Skinny Emergency Boutique, 30 day capsules supply to the retail/consumer level. The 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique have been found to contain Sibutramine which is a controlled substance by the DEA and poses significant health risks to consumers both products are from the same manufacturer 365 Skinny is the strongest form and the 365 Skinny Emergency is for people with high blood pressure, diabetes but not limited to other chronic illnesses.
Risk Statement: The 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique potentially can cause serious health risks such as seizures, tachycardia, palpitations, heart attacks and allergic reactions. Risks associated with this product are more likely with people who have high blood pressure, thyroid disease, men or woman over 65 or children under 16 years old. Je Dois L’avoir Boutique has not received any reports of adverse events related to this recall.
The product is used together with diet and exercise to assist with weight loss and is packaged in bottles of 30 capsules 600mg per capsule.
All lots and expiration dates of any of these products are being recalled. Je Dois L’avoir is recalling ALL 365 Skinny High Intensity Pills and 365 Emergency Boutique that it has sold to the public as seen below.
Nature’s Sunshine Issued Allergy Alert on Undeclared Milk in its "Love & Peas" Meal Replacement Shake
Nature’s Sunshine of Lehi, Utah is announcing that it initiated a voluntarily recall of certain lots of its Love & Peas product in April 2021 after being notified by an ingredient supplier that an ingredient used in the manufacturing of the affected product lots may contain milk. Customers with a milk allergy or severe sensitivity to milk may experience a serious allergic reaction if they consume the affected product.
Although Nature’s Sunshine made every effort to individually notify affected consumers in April 2021, it is making this announcement out of an abundance of caution in case any affected product remains in commerce.
The affected product was distributed between December 22, 2020 and April 8, 2021 throughout the United States through direct-to-consumer online sales and through independent distributors who sell product on-line or at independent health food stores.
The affected product is from lot numbers 001220292; 001223066; 001222059; 001215380; 001222934; 001218022; 001223890; 001220084; and 001224031. The lot number can be found stamped near the top of the reverse side of the packaging near the best by date.
Golden Natural Products Inc. Issues Allergy Alert on Undeclared Sulfites in Two Dried Apricot Products
Golden Natural Products, Inc. of Brooklyn, NY is recalling:
- Golden Natural Product Inc. brand Dried Apricot Subkhon with Bone, Net Wt. 16 oz (1 lb) 454 g; Lot: GC005; Best Before: 2023
- Golden Natural Product Inc. brand Dried Apricot Subkhon Jumbo, Net Wt. 16 oz (1 lb) 454 g; Lot: GC005; Best Before: 2023
because they contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.
The above products were distributed to CA, WA, and NY through wholesalers. Consumers would have purchased product through retail stores.
The products are packaged in 16oz plastic bags with white labels. The product codes, “Lot: GC005” and “Best Before: 2023” can be found on the back panel of both product packages.
Medical Devices Recalls
Eco-Med Pharmaceutical Issues Voluntary Recall of Eco-Gel 200
Etobicoke, Ontario (August 4, 2021) – Eco-Med Pharmaceuticals, Inc. today commenced a voluntary recall of certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination.
The product is also distributed as MediChoice Ultrasound Gel by Owens and Minor and Mac Medical Supply. These ultrasound gels are non-sterile and not indicated for sterile procedures.
Eco-Med is instructing all health care facilities to identify the affected products by lot number and immediately destroy or return products from affected lots to Eco-Med.
BD to Begin Remediation for BD Alaris™ System Software
FRANKLIN LAKES, N.J., July 29, 2021 /PRNewswireExternal Link Disclaimer/ BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the company will begin remediation for the February 4, 2020 BD Alaris™ System 1 recall through a new version of software.
The February 4, 2020 voluntary recall action notified customers of the following areas where the infusion pump may not operate as expected:
- Software errors related to System Error Code 255-XX-XXX
- Delay options programming
- Low Battery Alarm Failure
- Keep vein open (KVO)/End of Infusion alarms priority
- Use errors related to Custom Concentrations Programming
Under U.S. Food and Drug Administration (FDA) guidance, BD will release Alaris™ System software version 12.1.2 and associated ancillary software to remediate the affected software. Effective today, customers can begin scheduling remediation by contacting the BD Recall Support Center at 1-888-562-6018. The new software, which will be available at no cost to customers, is expected to remediate the issues identified in the February 4, 2020 recall notice and provide programming, operational and cybersecurity updates to affected devices; however, this software update has not been reviewed or cleared by the FDA.
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