Drugs Recalls
Meitheal Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Cisatracurium Besylate Injection, USP 10mg per 5mL Due to Mislabeling
Meitheal Pharmaceuticals, Inc. (“Meitheal”), announced today that it is voluntarily recalling one (1) lot of Cisatracurium Besylate Injection, USP 10mg per 5mL to the user level. The decision to recall the product was made after a product complaint revealed that a portion of Lot C11507A of cartons labeled as Cisatracurium Besylate Injection, USP 10mg per 5mL, containing 10-vials per carton, contained 10-vials mis-labeled as Phenylephrine Hydrochloride Injection, USP 100mg per 10mL. To date, Meitheal has not received reports of any adverse events or identifiable safety concerns attributed to the lot.
There is a reasonable probability that a patient who requires cisatracurium for muscle paralysis as part of general anesthesia is administered phenylephrine instead would not receive any skeletal muscle relaxation and could cause a hyperadrenergic state resolution in elevated blood pressure, arrhythmia and cardiac/brain ischemia. If this is not quickly diagnosed and treated, severe illness or death can occur.
There is a reasonable probability that a patient who requires phenylephrine to increase their blood pressure, such as patients with severely low blood pressure, especially resulting from septic shock who is administered cisatracurium instead could result in a fast onset of muscle paralysis and decrease in oxygen. If this is not quickly diagnosed and treated, severe illness or death can occur within minutes.
Cisatracurium Besylate Injection is used as a nondepolarizing neuromuscular blocker. The affected Cisatracurium Besylate Injection lot being recalled is C11507A, EXP. October 2021. The product can be identified as a 5mL vial stoppered with a rubber stopper and sealed with aluminum seal having an Aqua color flip-off seal. Meitheal commenced shipping the product to customers on August 19, 2020 which was distributed to wholesalers nationwide in the USA.
Food & Beverages Recalls
Dole Fresh Vegetables Announces Limited Voluntary Recall of Dole™ Endless Summer Salad Kit Due to Undeclared Allergens
Dole Fresh Vegetables, Inc. is voluntarily recalling a single lot code of Dole™ Endless Summer Salad Kit.
This recall is due to possible undeclared allergens (fish and egg) in Dole™ Endless Summer Salad Kit. The dressing and topping kit (masterpack) designed for a different Dole product was unintentionally used during a portion of the production of the salad. Dole Fresh Vegetables, Inc. is coordinating closely with regulatory officials. No illnesses nor allergic reactions have been reported to date in association with the recall. However, people who have an allergy to fish or eggs may have a serious or life-threatening allergic reaction if they consume this product.
The product lot code and Best if Used by Date is located on the upper right corner of each bag and the UPC code is located on the bottom right corner of the back of each bag. The impacted products were distributed in AZ, CA, CO, IA, ID, IL, KS, MN, MS, ND, OK, OR, PA, TX, UT, WA, and WI.
Hong Thai Foods Corp Issues Allergy Alert on Undeclared Milk Allergens in Golden Boy Custard Muffin Banana
Hong Thai Foods Corp. of Brooklyn, NY is recalling its 220 grams/7.76 ounce packages of Golden Boy Custard Muffin Banana 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 Golden Boy Custard Muffin Banana were distributed nationwide in retail stores. The product comes in a 220 grams/7.76 ounce, rigid clear plastic package marked with Best Before date of 29/01/2022 on the bottom. The product UPC code is 9555719731598.
Think! and Interpac Technologies, Inc., Issue Voluntary Recall and Allergy Alert on Undeclared Tree Nuts in Think! Protein + Fiber Oatmeal, Farmer’s Market Berry Crumble Products
think! and Interpac Technologies, Inc., of Woodland, California, a supplier of certain think! brand oatmeal products, have issued a voluntary recall on specific lots of think! Protein + Fiber Oatmeal, Farmer’s Market Berry Crumble products which may inadvertently contain undeclared tree nuts, including almonds and pecans. People who have an allergy or severe sensitivity to tree nuts, such as almonds and pecans, run the risk of serious or life-threatening allergic reaction if they consume the recalled products.
The recalled think! Protein + Fiber Oatmeal, Farmer’s Market Berry Crumble products were manufactured in the United States, distributed nationwide and reached consumers through retail stores and ecommerce websites, including www.thinkproducts.com.
Maine Grains, Inc. Issues Allergy Alert on Undeclared Soy in Organic Yellow Peas
Maine Grains, Inc. of Skowhegan, Maine is recalling 2,000 pounds of Organic Yellow Peas sold between 10.17.2019 and 11.1.2020 because it may contain undeclared soybeans. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Maine Grains Organic Yellow Peas were distributed in the Northeastern United States and to online customers who ordered through mainegrains.com. The majority of the product went to NYC.
Medical Devices Recalls
Safety Recall for Deluxe Heat Therapy Massager
Wahl Clipper Corporation is voluntarily recalling all Deluxe Heat Therapy Massagers, Model 4212. Discontinue use immediately. The connection between the massager and heat attachment can overheat causing smoke or spark, which may pose a fire hazard. The image below shows the area where smoke or sparks may appear.
If you own a Deluxe Heat Therapy Massager, call us at 800-767-9245 or email at techsupport@wahlclipper.com. We will facilitate the free return of your unit in exchange for a full refund plus an additional $10 for this inconvenience. Your safety is important to Wahl Clipper Corporation. If you have any questions concerning this voluntary product recall, please contact us.
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