Drug Recalls
Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune’s Fix
Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets Products Due to the Presence of Tianeptine
KANSAS CITY, Mo., Jan. 28, 2024 /PRNewswire-PRWeb/ -- Neptune Resources, LLC is voluntarily recalling All lots of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets to the consumer level. Neptune Resources LLC's distribution channels have not reported any adverse events from the use of its products. The products are being recalled because they contain tianeptine, an ingredient that is not FDA-approved for any medical use. The presence of tianeptine renders the products unapproved drugs for which safety and efficacy have not been established and, therefore, are subject to recall.
Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing
FOR IMMEDIATE RELEASE – January 24, 2024 – Woburn, Massachusetts, Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 mg tablets and found tablets of Carbinoxamine Maleate, an antihistamine drug. Upon learning of the incident, the manufacturer opened a product complaint and an investigation followed.
Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury. Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder. For patients with Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy (sleep disorder) there is a reasonable probability that accidents or injuries that occur due to the sedating effects of carbinoxamine, could lead to ongoing disability or death in severe cases, particularly if individuals who use it (unaware that they have not received Zenzedi®) engage in activities requiring significant focus and alertness (e.g., driving, operating heavy machinery).
Haleon Issues Voluntary Nationwide Recall of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products Due to Microbial Contamination
FOR IMMEDIATE RELEASE – January 24, 2024 – Warren, NJ, Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination.
In immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal infection. In non-immunocompromised consumers, the population most likely to use the product, life-threatening infections are not likely to occur. However, the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out.
Food & Beverage Recalls
Byrne Dairy Recalls Mighty Fine Chocolate Ice Cream in Half Gallons Dated 10/4/2024 Due to Undeclared Peanuts
Byrne Dairy, Inc. of Syracuse, New York is voluntarily recalling its Byrne Dairy Mighty Fine Chocolate Ice Cream in half gallon cartons with a Last Date of Sale of 10/4/2024 because it may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume the product.
Product was distributed in retail stores throughout Upstate New York.
The product is packaged in ½ gallon cardboard containers printed with ‘Byrne Dairy Might Fine Chocolate Ice Cream’ with ‘Last Date of Sale: 10/4/2024’ printed on the side of the container. The recall involves no more than 250 half gallon units.
Truong Giang Distributor Corp Issues Allergy Alert on Undeclared Sulfites in Dried Mango
TRUONG GIANG DISTRIBUTOR CORP of Philadelphia, PA is recalling Golden Owl Dried Mango, because it may 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.
Product was distributed nationwide in retail stores.
This product is packaged in 7 oz (100g) clear plastic containers with UPC 816710-024461 located on the left side of the container.
Utz Quality Foods Issues Allergy Alert on Undeclared Milk in Utz® Wavy Original Potato Chips in Metro New York Area
HANOVER, PA. (BUSINESS WIRE) – Utz Quality Foods, LLC., is issuing a voluntary recall for 88 cases of Utz® 2.75 oz. Wavy Original Potato Chips due to an undeclared milk allergen. This recall was initiated after Utz learned that approximately 1200 single-serve bags contained Utz® Wavy Original Potato Chips flavored with seasoning instead of plain Utz® Wavy Original Potato Chips. People who have an allergy or severe sensitivity to milk may run the risk of an allergic reaction if they consume these products.
The items subject to this voluntary recall were distributed to retail outlets only in New York State and primarily within New York City.
Medical Device Recalls
Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Nurse Assist Sterile Saline Placed Into the Following Kits; AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure Kit
On December 22, 2023, Aligned Medical Solutions, Billings, MT, initiated a nationwide recall of Nurse Assist Sterile Saline which is piggybacked [attached to the outside of the kit in a separate pouch] to the following kits: AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure Kit.
Read Comments