Drug Recalls
Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination
Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results.
Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions such as Lambert Eaton Syndrome (LEMS) increases the concern for serious infections.
The product is used as a treatment for LEMS in patients ages 6 to less than 17 and is packaged in 100 count bottles (NDC: 49938-110-01). The affected Ruzurgi® (amifampridine) tablets lots include the following control numbers and expiration dates:
Control Number 18038, Expiration 03/2023
Control Number 18039, Expiration 03/2023
Control Number 18079, Expiration 05/2023
The Control Number is located to the right of the bottle’s front panel below the D2 Barcode.
Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit, Due to a Mix-Up of the Diluent Included in the Kit
Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle.
ICU Medical Issues a Voluntary Nationwide Recall of Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution Due to the Presence of Particulate Matter
ICU Medical, Inc. is voluntarily recalling one lot (2,112 units) of Aminosyn II, 15%, An Amino Acid Injection, Sulfite Free intravenous (IV) solution to the hospital/user level due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other particles. ICU Medical became aware of this issue while inspecting retain samples as part of routine process.
Administration of a drug product that contains particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. To date, ICU Medical, Inc. has not received reports of adverse events or illness related to this recall.
Medical Devices Recalls
Magellan Diagnostics, Inc. Expands Voluntary Recall of LeadCare® Test Kits
Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today announced its wholly owned subsidiary, Magellan Diagnostics, Inc. (“Magellan”), expanded the Class I recall of its LeadCare® II Blood Lead Test Kits, LeadCare Plus® Blood Lead Test Kits, and LeadCare Ultra® Blood Lead Test Kits (the “LeadCare Test Kits”) for the detection of lead in whole blood.
Magellan provides two controls in the test kits which are designed to mimic blood and are spiked with lead to specific target values with an associated acceptable range. Results of the control tests within the acceptable range indicate that the system is operating properly before testing patient samples. In May 2021, Magellan initiated this voluntary recall after identifying an ongoing issue with testing of the controls included in the LeadCare Test Kits. Magellan continues to investigate this issue and has conducted extensive testing to evaluate potential root causes.
Food & Beverage Recalls
Velvet Ice Cream Voluntarily Recalls Raspberry Fudge Cordial Ice Cream Due to Undeclared Peanuts
Velvet Ice Cream has issued a voluntary recall of its 56oz Raspberry Fudge Cordial Ice Cream because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts could experience a serious or life-threatening allergic reaction if they consume this product.
The impacted product was distributed to retail stores in Ohio, Kentucky, Indiana and West Virginia starting in late July with a production date of July 14, 2021. The affected product can be identified by UPC 0-7068210049-7 and the following codes printed on the bottom of the carton: A2 19521 26-012 and To date, there are no reported illnesses associated with this recall.
McKee Foods Issues Allergy Alert on Undeclared Pecans in Little Debbie® Mini Nutty Buddy Cookie Bites Sandwich Cookies
McKee Foods of Collegedale, Tenn., is recalling 25 cases of Little Debbie® Mini Nutty Buddy Cookie Bites Sandwich Cookies, because they may contain undeclared pecans. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume these products. This recall does not impact Little Debbie® Nutty Buddy® Wafer Bars or any other Little Debbie products.
Dole Fresh Vegetables Announces Precautionary Limited Recall of Curly Leaf Parsley Due to Possible Contamination with Non-O157 Shiga-Toxin Producing E. coli
Monterey, California – September 10, 2021 – Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of conventional Curly Leaf Parsley. The product being recalled is Dole® Curly Leaf Parsley, with harvest dates of August 18, 2021, and August 19, 2021. A random, routine regulatory sample collected in Michigan tested positive for non-O157 STEC (Shigatoxin-producing E. coli). Dole Fresh Vegetables is coordinating closely with regulatory officials in connection with the Recall; no illnesses have been reported.
Shiga-toxin-producing E. coli is an organism that can cause foodborne illness in a person who eats a food item contaminated with it. Symptoms of infection may include stomach cramps, diarrhea, and vomiting.
The illness primarily impacts elderly individuals, children, and people with weakened immune systems. Most healthy adults and children rarely become seriously ill.
The product was distributed to retail stores, wholesalers, and distributors in two pack sizes – 60-count (74 cases) and 30-count (39 cases). Retailers, wholesalers, and distributors can find the product code in the lower right portion of the PTI label. The product code for both the 60 count cases and the 30 count cases is 0 07143 000310 3. Individual bunches of parsley purchased by consumers have a price look-up (PLU) number on binding twist-ties of 4899 and a UPC code of 0 3383 80330 0. The Curly Leaf Parsley subject to this Recall was distributed in FL, IA, MI, MN, and MO.
Weis Markets Issues an Allergy Alert for $7 Crab Cake Meal Due to Undeclared Milk Allergen
Weis Markets today announced it has issued a recall for its in-store $7 Crab Cake Meal for not declaring milk as an allergen on its label. Food allergies are an immune system reaction that occurs soon after eating a food containing an allergen. Even a tiny amount of the allergy-causing food can trigger signs and symptoms such as digestive problems, hives or swollen airways. In some people, a food allergy can cause severe symptoms or even a life-threatening reaction known as anaphylaxis.
The product is in a 3-compartment container sold in the deli. This recall is being issued as a precaution. The sell by dates affected are 8/25/2021 through 9/05/2021. The issue was discovered during a routine inspection. Customers may return the product for a full refund.
The Baking Institute Bakery Co. Issues Allergen Alert on Undeclared Walnuts, Coconuts and Milk in “Carrot Cake”
The Baking Institute Bakery Co. of Northbrook, Illinois is recalling “Carrot Cake” because it may contain undeclared walnuts, coconut, and milk. People who have an allergy or severe sensitivity to walnuts, coconut and milk run the risk of serious or life-threatening allergic reaction if they consume these products.
The “Carrot Cake” was distributed to retail stores in northern Illinois.
The product comes in a 6 inch and 8-inch round size and is packaged in a plastic container with a black base and a clear dome lid container. The product is marked with the following UPC codes; Carrot Cake 6” (UPC code 813749010014) and Carrot Cake 8”-(UPC code- 8500244836235).
KBF Inc. Issues Allergy Alert on Undeclared Milk Allergens in Banoful Top Orange Biscuit
KBF Inc. of Astoria, NY, is recalling its 8.11 ounce packages of “Banoful Top Orange Biscuit” food treats because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product.
The recalled “Banoful Top Orange Biscuit” were distributed nationwide in retail stores and through mail orders. The product comes in an 8.11 ounce, orange plastic package marked with MFG 15.06.2020 on the top and with an expiration date of 14/06/2022 stamped on the side. The product UPC code is 8-941114-001427.
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