July 2022 recalls

561 recalls were announced in July 2022.

What the numbers show

Critical: 6
Severe: 96
High: 416
Moderate: 40
Low: 3

Of the 561 recalls this month scored against our rubric, 1% are Critical, 17% are Severe.

Which agencies issued them

101–200 of 561

HighFDA (Drugs)·D-1273-2022·2022-07-27
Oxytocin Injectable Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Oxytocin 30 Units/500 mL injectable solution due to lack of sterility assurance. Approximately 1,810 bags with lot codes OX2013C and OX2013E were distributed nationwide.
Product
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1251-2022·2022-07-27
Epinephrine Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 134,385 epinephrine injection syringes nationwide due to lack of assurance of sterility. No illnesses have been reported.
Product
EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1281-2022·2022-07-27
Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 18,840 syringes of Succinylcholine Chloride Injection nationwide because the manufacturing process cannot be assured to have maintained sterility.
Product
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-919-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1339-2022·2022-07-27
Dietary Supplement Marketed as Unapproved Drug Recalled by FDA
Launch Sequence Capsules, a dietary supplement sold in 60-count bottles, were recalled because they were marketed without FDA approval as a drug based on label claims.
Product
Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1463-2022·2022-07-27
Truffle Recall: Undeclared Tree Nuts Present Allergen Risk
Queen Bee Gardens is recalling Midnight Gold Classic Truffles for potentially containing undeclared tree nuts, which pose a risk to allergic consumers. Distribution included Colorado, New Mexico, Wyoming, and nationwide online.
Product
Midnight Gold Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11070 2. Ingredients: Dark chocolate, honey, butter (pasteurized cream, salt), cream, non-fat dry milk, whey, almonds, milk chocolate, natural flavor, salt, soda, agar, algin & lecithin.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1452-2022·2022-07-27
SurgiCount+ System software error bypasses sponge tracking alerts
A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.
Product
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
Category
Medical Device
Distribution
2 states
HighFDA (Food)·F-1465-2022·2022-07-27
Bee Joyful Bars Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Bee Joyful Bars due to undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. The product poses a health risk to consumers with tree nut allergies.
Product
Bee Joyful Bars. Net wt. 1.5 oz. PLU Code: 788394 18565 6. Ingredients: Dark chocolate (sugar, chocolate liquor processed with potassium carbonate, cocoa butter, milk fat [butter], sunflower lecithin & pure vanilla), Honey, Butter (Pasteurized cream & Salt), Cream, Coconut, A
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1419-2022·2022-07-27
Orthopedic Surgical Guide with Defective Spring Subject to Corrosion
DePuy Orthopaedics is recalling 872 units of the ATTUNE Measured Sizing and Rotation Guide due to a manufacturing defect. A galvanized steel spring was used instead of stainless steel, which may cause corrosion and surgical complications.
Product
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1432-2022·2022-07-27
BD Connecta Stopcock Recalled for Potential Housing Leakage
Becton Dickinson is recalling its BD Connecta Stopcock due to potential leakage at the housing component, which may interrupt treatment and cause exposure to biohazardous material.
Product
BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1429-2022·2022-07-27
Revie Superfoods Smoothie Recalled for Potential Norovirus Contamination
Revie Superfoods Berry Blu smoothie mix is recalled due to potential norovirus contamination from frozen raspberries. The recall affects 57,960 units distributed to retailers in Pennsylvania, California, Illinois, and Texas.
Product
Revie Superfoods Berry Blu 194g Ready-to-Blend Blueberry Creamsicle Smoothie Made in Canada UPC 8 54681 00005 3 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
HighFDA (Food)·F-1499-2022·2022-07-27
Dark Raspberry Classic Snack Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Dark Raspberry Classic snacks due to undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts) that may be present, posing a risk to consumers with tree nut allergies.
Product
Dark Raspberry Classic. Net wt. 1.4 oz. UPC 788394 10003 1.
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1266-2022·2022-07-27
Morphine Sulfate Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 8,985 syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1455-2022·2022-07-27
Recall: Cherry Classic Truffle Contains Undeclared Tree Nuts
Queen Bee Gardens recalled Cherry Classic Truffles (1.4 oz) due to undeclared tree nuts: pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.
Product
Cherry Classic Truffle. Net Wt. 1.4 oz. PLU Code: 788394 11015 3. Ingredients: Milk chocolate, honey, butter (pasteurized cream & salt), cream, cherries, pecans, non-fat dry milk, whey, agar, algin, lecithin, citric acid & natural flavor.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1440-2022·2022-07-27
Nexiva Infusion Device Stopcock May Leak During Treatment
Becton Dickinson is recalling Nexiva infusion devices with pink stopcock components due to potential leakage at the housing that could interrupt treatment or expose patients to infusate and biohazardous material.
Product
Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1420-2022·2022-07-27
Ambu VivaSight 2 DLT endobronchial tubes recalled for cuff leak risk
Ambu Inc. is recalling the VivaSight 2 DLT endobronchial tube system due to reports of cuff leaks or ruptures that could compromise airway security during intubation procedures.
Product
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1411-2022·2022-07-27
Medical Device Recall: Hill-Rom PRO+ Mattress Microclimate Feature Failure
Hill-Rom PRO+ mattresses are being recalled for a Microclimate Management feature failure that could increase pressure ulcer risk in patients. The recall affects 200 units distributed in the US and Canada.
Product
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2022·2022-07-27
Hill-Rom Mattress Microclimate Feature Failure Increases Pressure Ulcer Risk
Certain Hill-Rom PRO+ MRS mattresses may have a Microclimate Management feature failure that increases patient pressure ulcer risk. Affected units were distributed to 25+ U.S. states and Canada.
Product
Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1434-2022·2022-07-27
Revie Superfoods Raspberry & Mango Smoothie Recalled for Potential Norovirus
Revive Organics is recalling Revie Superfoods Raspberry & Mango Smoothie products because they may contain norovirus from contaminated raspberries. Consumers in PA, CA, IL, and TX who have purchased this product should not consume it.
Product
Revie Superfoods Raspberry & Mango 188g Ready-to-Blend Smoothie Made in Canada UPC 8 54681 00026 8 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
HighFDA (Food)·F-1462-2022·2022-07-27
Macadamia Classic Truffles Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Macadamia Classic Truffles because they may contain undeclared tree nuts including almonds, coconut, and walnuts. The product poses allergen risks to consumers with tree nut allergies.
Product
Macadamia Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11060 3. Ingredients: Milk chocolate (sugar, milk, cocoa butter, chocolate liquor, soya lecithin and pure vanilla) honey, butter (pasteurized cream, salt), cream, roasted & sea salted macadamias, pecans, non-fat dry
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1470-2022·2022-07-27
Chocolate Candy Products Recalled Due to Undeclared Tree Nuts
Queen Bee Gardens is recalling English Toffee chocolate products that may contain undeclared tree nuts. Consumers with tree nut allergies should not consume these products.
Product
***English Toffee D/C Bites. PLU Code: 788394 10110 6. Ingredients: Honey, dark chocolate (sugar, chocolate liquor processed with potassium carbonate, cocoa butter, milk fat [butter], sunflower lecithin, pure vanilla), butter (pasteurized cream, salt), pecans, cream, dry milk, w
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1458-2022·2022-07-27
Fudge Classic Truffle recalled for undeclared tree nuts
Queen Bee Gardens is recalling Fudge Classic Truffle candy because it may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.
Product
Fudge Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11045 0. Ingredients: Dark chocolate, milk chocolate, honey, butter (pasteurized cream & salt), cream, non-fat dry milk, whey, agar, algin, lecithin & natural flavors.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2022·2022-07-27
BD Connecta Plus1 360 Infusion Connector: Potential Housing Leakage
Becton Dickinson is recalling certain BD Connecta Plus1 360 Blue Blend infusion connectors due to potential leakage at the housing stopcock that could interrupt treatment and expose patients to contamination and biohazardous material.
Product
BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1453-2022·2022-07-27
Black Forest Classic Truffle recalled for undeclared tree nuts
Queen Bee Gardens is recalling Black Forest Classic Truffle chocolates that may contain undeclared tree nuts not listed on the label.
Product
Black Forest Classic Truffle. Net Wt. 1.4 oz. PLU Code: 788394 11900 2. Ingredients: Dark chocolate, honey, butter (pasteurized cream & salt), cream, cherries, pecans, almonds, non-fat dry milk, whey, agar, algin, lecithin & natural flavors.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2022·2022-07-27
BD Connecta Plus3 infusion connector recalled for potential stopcock leakage
Becton Dickinson is recalling BD Connecta Plus3 White Blend infusion connectors (Lot 1127328) due to potential stopcock leakage. The defect may interrupt treatment, expose patients to biohazardous material, or cause under-infusion.
Product
BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1409-2022·2022-07-27
Aesculap Aeos Digital Microscope robotic arm malfunction requires system restart
Aesculap Implant Systems is recalling the UR5 robotic arm component in its Aeos Digital Microscope System due to malfunction that prevents arm movement and requires system restart.
Product
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1436-2022·2022-07-27
BD Connecta 3-Way Stopcocks Recalled Due to Potential Leakage
Becton Dickinson recalls BD Connecta 3-Way Stopcocks due to potential leakage at the housing that may delay treatment and expose patients to biohazardous material.
Product
BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1451-2022·2022-07-27
Almond Coconut Truffles Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Almond Coconut Classic Truffles for undeclared tree nuts (pecans, almonds, coconut, macadamia, walnuts). The affected product was sold in Colorado, New Mexico, Wyoming, and nationwide online.
Product
Almond Coconut Classic Truffle. Net Wt. 1.4 oz. PLU Code: 788394 11025 2. Ingredients: Milk & dark chocolate, honey, butter (pasteurized cream & salt), cream, coconut, almonds, non-fat dry milk, whey, natural flavors, agar, algin & lecithin. Note: Typo on website should be
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1493-2022·2022-07-27
Toffee Bites Patties Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Toffee Bites Patties Gift Boxes due to undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, and walnuts) that may pose a risk to people with nut allergies.
Product
Toffee Bites Patties Gift Box. Net wt. 3 oz. PLU Code: 788394 17777 4.
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1264-2022·2022-07-27
Lidocaine HCl injection syringes recalled due to sterility assurance failure
Nephron Sterile Compounding Center has recalled 37,310 syringes of Lidocaine HCl Injection USP 1% nationwide due to lack of assurance of sterility. Affected lots expire between August and October 2022.
Product
Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-985-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1486-2022·2022-07-27
Honeymoons Dark Chocolate Cashew Recalled for Undeclared Tree Nuts
Honeymoons Dark Chocolate Cashew products may contain undeclared tree nuts including pecans, almonds, coconut, macadamia, and walnuts. The product is being recalled from Queen Bee retail locations in Colorado, New Mexico, Wyoming, and nationwide online.
Product
Honeymoons Dark Chocolate Cashew. PLU Code: 788394 14864 4.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1503-2022·2022-07-27
Chicken Breading Recalled Due to Undeclared Wheat Allergen
Belmatt Inc is recalling Targil's Hot Tails Louisiana Crawfish House Chicken Breading (5,083 pounds, Lot 0206102202) due to undeclared wheat. The product was distributed in Louisiana and poses a risk to consumers with wheat allergies.
Product
Targil's Hot Tails Louisiana Crawfish House Chicken Breading packaged in 25lb boxes
Category
Food
Distribution
1 state
HighFDA (Food)·F-1532-2022·2022-07-27
Lemon Muffins Recalled Due to Plastic Material Contamination
Portland Specialty Baking is recalling Lemon Muffins due to plastic material contamination. The affected product was distributed in California, Idaho, and Oregon.
Product
Lemon Muffins, item # 802387, are packaged in paper tray and covered with plastic film shrink wrap. Each tray contains 6 pieces and there are 6 trays per master case. PSB (Portland Specialty Baking) master case label is read in parts: "***PSB***LEMON MUFFINS *** 802387***6/36 O
Category
Food
Distribution
3 states
HighFDA (Food)·F-1497-2022·2022-07-27
Valentine Gift Box Recall Due to Undeclared Tree Nuts
Queen Bee Gardens is recalling Valentine Gift Box products that may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts). Products were distributed through 10 retail locations in Colorado, New Mexico, Wyoming, and nationwide online.
Product
Valentine Gift Box. Net wt. 7.5 oz. PLU Code: 788394 17700 2.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1432-2022·2022-07-27
Coconut cream smoothie recalled for potential norovirus contamination
Revive Organics is recalling Revie Superfoods Coconut Cream 190g due to potential norovirus contamination from individually quick-frozen raspberries. Affected units were distributed to consumers in Pennsylvania, California, Illinois, and Texas.
Product
Revie Superfoods Coconut Cream 190g Ready-to-Blend Coconut Delight Smoothie Made in Canada UPC 8 54681 00016 9 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
HighFDA (Food)·F-1484-2022·2022-07-27
Honeymoons Dark Chocolate Almond Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honeymoons Dark Chocolate Almond for undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. The product was distributed to retail locations in Colorado, New Mexico, and Wyoming, and nationwide online.
Product
Honeymoons Dark Chocolate Almond. PLU Code: 788394 14792 0.
Category
Food
Distribution
Distributed nationwide
HighNHTSA·22V540000·2022-07-27
Micro Bird Recalls 2021-2022 School Buses for Window Panel Attachment Defect
Micro Bird is recalling 2021-2022 G5, MB II, and T-Series school buses because window panels may detach in a crash.
Product
MICRO BIRD — MICRO BIRD G5 SCHOOL BUS, T-SERIES SCHOOL BUS, MB II SCHOOL BUS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1433-2022·2022-07-27
Revie Superfoods Heart Beet Smoothie Mix Recalled for Potential Norovirus
Revive Organics is recalling Revie Superfoods Heart Beet 206g Ready-to-Blend smoothie mix due to potential norovirus contamination in frozen raspberries used in the product. Consumers should not consume affected lots.
Product
Revie Superfoods Heart Beet 206g Ready-to-Blend Cardamom + Beet Smoothie Made in Canada UPC 8 53267 00112 5 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
HighFDA (Food)·F-1474-2022·2022-07-27
Honey Caramels Caramel Apple Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honey Caramels Caramel Apple because the product may contain undeclared tree nuts. The recall affects products sold at ten retail locations and online nationwide.
Product
Honey Caramels Caramel Apple. Net wt. 5.87 oz. PLU Code: 788394 12204 0. Ingredients: Honey, butter (pasteurized cream & salt), cream, almonds, nonfat dry milk, whey, natural flavors, lecithin, algin & agar.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1495-2022·2022-07-27
Truffle Gift Box Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Truffle Gift Boxes due to undeclared tree nuts that may pose a hazard to allergic consumers. Products were sold at retail locations in Colorado, New Mexico, Wyoming, and nationwide online.
Product
Truffle Gift Box PLU Code: 788394 17655 5
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1492-2022·2022-07-27
Honeymoon Cinna-Bee Patties recalled due to undeclared tree nuts
Queen Bee Gardens is recalling Honeymoon Cinna-Bee Patties due to potential undeclared tree nuts: pecans, almonds, coconut, macadamia nuts, and walnuts. Products were distributed in Colorado, New Mexico, Wyoming, and nationwide online.
Product
Honeymoon Cinna-Bee Patties. PLU Code: 788394 14892 7
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1472-2022·2022-07-27
Honey Caramels Blue Raspberry Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honey Caramels Blue Raspberry due to undeclared tree nuts (pecans, almonds, coconut, macadamia, walnuts). The product poses a serious risk to consumers with tree nut allergies.
Product
Honey Caramels Blue Raspberry. Product available in 5.87 oz. bag, 1 lb. bag, 3 lb. bag, 6 lb. bag. PLU Code for 5.87 oz. bag: 788394 12675 8.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1481-2022·2022-07-27
Honey Caramels Recalled for Undeclared Tree Nuts
Queen Bee Gardens recalls Honey Caramels Strawberry Lemonade due to undeclared tree nuts. The product may contain pecans, almonds, coconut, macadamia nuts, or walnuts, posing a risk to consumers with tree nut allergies.
Product
Honey Caramels Strawberry Lemonade. Net wt. 5.87 oz. PLU Code: 788394 12154 8. Ingredients: Honey, butter (pasteurized cream & salt), cream, natural flavors, nonfat dry milk, whey, agar, algin, natural colors, citric acid and lecithin.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1471-2022·2022-07-27
Honey Caramels Almond Coconut Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honey Caramels Almond Coconut due to potential presence of undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts). Consumers allergic to tree nuts should not consume this product.
Product
Honey Caramels Almond Coconut. Product available in 5.87 oz. bag, 1 lb. bag, 3 lb. bag, 6 lb. bag. PLU Code for 5.87 oz bag: 788394 12004 6. Ingredients: Honey, butter (pasteurized cream & salt), cream, almonds, coconut, nonfat dry milk, whey, natural flavors, lecithin, algi
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1464-2022·2022-07-27
Bee Energy Bar recalled due to undeclared tree nuts
Queen Bee Gardens is recalling Bee Energy Bars due to undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.
Product
Bee Energy Bar. Net wt. 1.5 oz. PLU Code: 788394 18559 5. Ingredients: Dark chocolate (sugar, chocolate liquor, cocoa butter, milk fat [butter], sunflower lecithin, pure vanilla), honey, almonds, butter (pasteurized cream, salt), coconut, gluten free oats, dried cranberries
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1475-2022·2022-07-27
Honey Caramels Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honey Caramels Cinna Honey due to potential undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts). Affected products were sold at 10 retail locations in Colorado, New Mexico, and Wyoming, as well as nationwide via internet.
Product
Honey Caramels Cinna Honey. Net wt. 5.87 oz. PLU Code: 788394 12404 4. Ingredients: Honey, butter (pasteurized cream & salt), cream, nonfat dry milk, whey, cinnamon oil, beet juice (color), lecithin, algin & agar.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1506-2022·2022-07-27
Chicken Breading Recalled Due to Undeclared Wheat Allergen
Belmatt Inc is recalling Targil's St. Amand's Chicken Breading due to undeclared wheat. The product was distributed in Louisiana and poses a health risk to those with wheat allergies or celiac disease.
Product
Targil's St. Amand's Chicken Breading packaged in 25lb boxes
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-1248-2022·2022-07-27
Injectable Lidocaine Syringes Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center has recalled 1,380 prefilled lidocaine syringes nationwide due to inability to confirm product sterility.
Product
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC:
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1476-2022·2022-07-27
Honey Caramels Creamy Fudge Recalled for Undeclared Tree Nuts
Queen Bee Gardens, LLC is recalling Honey Caramels Creamy Fudge because the product may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, and walnuts). People with tree nut allergies should not consume this product.
Product
Honey Caramels Creamy Fudge. Net wt. 5.87. PLU Code: 788394 12354 2.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1439-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Lecithin
Chuckanut Bay Foods recalls cheesecake bites for undeclared soy lecithin in the chocolate compound. The label incorrectly states sunflower lecithin, creating an allergic reaction risk for consumers with soy allergies.
Product
Item 34021-12, Chuckanut Bay Cheesecake Bites Berry. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. Net Wt. 6.4 oz. UPC 6 03812 34021 2. Item 35009-12, Chocolate Covered Berry Cheesecake Bites. Edible brand. Distributed by Wish Foods, LLC.
Category
Food
Distribution
13 states
HighFDA (Food)·F-1468-2022·2022-07-27
QBee Sea Salt Caramel Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling QBee Sea Salt Caramel due to undeclared tree nuts. The affected product was sold at ten retail locations in Colorado, New Mexico, and Wyoming, and via internet sales.
Product
QBee Sea Salt Caramel. Net wt. 1 oz. PLU Code: 788394 11010 8.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1449-2022·2022-07-27
Aesculap Sterile Disposable Fleece Drape Recalled Due to Packaging Seal Integrity Issue
Aesculap recalls 4500 sterile disposable fleece drapes (Product code GA414) due to unvalidated packaging seal integrity, which may compromise sterility assurance. Distribution occurred in 14 U.S. states.
Product
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Category
Medical Device
Distribution
14 states
HighFDA (Food)·F-1443-2022·2022-07-27
Cheesecake Bites Recalled for Undeclared Soy Lecithin Allergen
Chuckanut Bay Cheesecake Bites Lemon are being recalled due to undeclared soy lecithin in the product. The label incorrectly lists sunflower lecithin as an ingredient, posing a risk to consumers with soy allergies.
Product
Item 34032-12, Chuckanut Bay Cheesecake Bites Lemon. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. Net Wt. 6.4 oz. UPC 6 03812 34032 8. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CHOCOLATE COMPOUND (sunflower lecithin**
Category
Food
Distribution
13 states
HighFDA (Food)·F-1469-2022·2022-07-27
English Toffee Chocolate Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling English Toffee Milk Chocolate and related products containing undeclared tree nuts. Products were sold at retail locations in Colorado, New Mexico, Wyoming, and nationwide online.
Product
English Toffee Milk Chocolate. PLU Code: 788394 10008 6. English Toffee M/C Bites. PLU Code: 788394 10015 4. English Toffee Bites Individual. PLU Code: 788394 10115 1
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1488-2022·2022-07-27
Honeymoons Milk Chocolate Pecan recalled for undeclared tree nuts
Queen Bee Gardens is recalling Honeymoons Milk Chocolate Pecan candies due to the potential presence of undeclared tree nuts. Consumers with tree nut allergies should not consume this product.
Product
Honeymoons Milk Chocolate Pecan. PLU Code: 788394 14684 8. Ingredients: Honey, milk chocolate (sugar, milk, cocoa butter, chocolate liquor, sunflower lecithin and pure vanilla), pecans, butter (pasteurized cream, salt) cream, nonfat dry milk, whey, sunflower lecithin, algin, a
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1487-2022·2022-07-27
Chocolate Cashew Candy Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honeymoons Ivory Chocolate Cashew candy because it may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts, which can cause severe allergic reactions.
Product
Honeymoons Ivory Chocolate Cashew. PLU Code: 788394 14900 9
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1482-2022·2022-07-27
Honey Caramels Recalled for Undeclared Tree Nut Allergens
Queen Bee Gardens recalls Honey Caramels Vanilla products that may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts), which can harm consumers with allergies.
Product
Honey Caramels Vanilla. PLU Code: 788394 12332 0 Product available in 5.87 oz. bag, 1 lb. bag, 3 lb. bag, 6 lb. bag.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1450-2022·2022-07-27
Chocolate Cheesecake Bites Recalled for Undeclared Soy Lecithin
Chuckanut Bay Foods is recalling Chocolate Cheesecake Bites because the label lists Sunflower Lecithin when the product actually contains Soy Lecithin, an undeclared allergen. Consumers with soy allergies face a potential health risk.
Product
Item 32017-56, Chocolate Cheesecake Bites BULK. Perishable - Keep Refrigerated. There are 14 pieces per pack and 56 packs per case. Firm did not provide label.
Category
Food
Distribution
13 states
HighFDA (Food)·F-1435-2022·2022-07-27
Revive Superfoods Strawberry Zen Smoothie Mix Recalled for Norovirus Risk
Revive Superfoods Strawberry Zen smoothie mix is being recalled due to potential norovirus contamination in IQF raspberries used as an ingredient. The recall affects 57,960 units distributed to consumers in Pennsylvania, California, Illinois, and Texas.
Product
Revie Superfoods Strawberry Zen 222g Ready-to-Blend Strawberry Banana Smoothie Made in Canada UPC 8 54681 00003 9 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1445-2022·2022-07-27
Spinal fusion cross connector recalled for insufficient clamping force
Aesculap is recalling AESCULAP S4 Cervical Cross Connectors used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to loosen or shift on the spinal rods.
Product
AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1443-2022·2022-07-27
Spinal Fusion Implant Cross Connectors Recalled for Insufficient Clamping Force
Aesculap is recalling its S4 Cervical Cross Connector used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to move on the rods or shed particles.
Product
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1491-2022·2022-07-27
Honeymoon Patties Mint Bee Patties recalled for undeclared tree nuts
Queen Bee Gardens is recalling Honeymoon Patties Mint Bee Patties because they may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts). The product was sold at retail locations in Colorado, New Mexico, Wyoming, and nationwide online.
Product
Honeymoon Patties Mint Bee Patties. Net wt. 8 oz. PLU Code: 788394 14896 5
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1459-2022·2022-07-27
German Chocolate Truffle Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling German Chocolate Truffles because they may contain undeclared tree nuts. The recall affects products sold in Colorado, New Mexico, Wyoming, and through nationwide internet sales.
Product
German Chocolate Truffle. Net Wt. 1.4 oz. PLU Code: 788394 11058 0.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1424-2022·2022-07-27
Randox Cholesterol In Vitro Diagnostic Kits Fail Stated Performance Specifications
Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.
Product
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1496-2022·2022-07-27
Truffle Dark Gift Box Recalled for Undeclared Tree Nuts
Queen Bee Gardens recalls Truffle Dark Gift Box due to undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. The product poses a risk to consumers with tree nut allergies.
Product
Truffle Dark Gift Box, 12 pc., 6 oz. PLU Code: 788394 17660 9
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1461-2022·2022-07-27
Queen Bee Gardens Huckleberry Truffles Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Huckleberry Truffles because they may contain undeclared tree nuts (pecans, almonds, coconut, macadamia, walnuts). Products were sold at retail locations in Colorado, New Mexico, Wyoming, and nationwide via internet.
Product
Huckleberry Truffle. Net wt. 1.4 oz. PLU Code: 788394 11057 3. Ingredients: Dark chocolate (sugar, chocolate liquor processed with potassium carbonate, cocoa butter, milk fat [butter], HONEY, "Ivory" chocolate (sugar, cocoa butter, whole & non-fat milk solids, sunflower lecith
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1445-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Lecithin
Chuckanut Bay Foods is recalling Dipped Cheesecake Bites Chocolate because the product label lists Sunflower Lecithin when it actually contains undeclared Soy Lecithin, a potential allergen.
Product
Item 39417-12, Chuckanut Bay DIPPED CHEESECAKE BITES Chocolate. Perishable - Keep Refrigerated. There are 4 pieces per pack and 12 packs per case. Net Wt. 3.2 oz. per package. UPC 6 03812 39417 8. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CANE SUGAR, EGGS,
Category
Food
Distribution
13 states
HighFDA (Devices)·Z-1431-2022·2022-07-27
BD Connecta Infusion Stopcock Recall Due to Potential Housing Leakage
BD Connecta Stopcock infusion devices may leak at the housing component, potentially delaying or interrupting treatment and exposing patients to biohazardous material. The recall affects 485,000 units distributed worldwide.
Product
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1485-2022·2022-07-27
Honeymoons Milk Chocolate Cashew recalled for undeclared tree nuts
Queen Bee Gardens is recalling Honeymoons Milk Chocolate Cashew candy due to undeclared tree nuts including pecans, almonds, coconut, macadamia, and walnuts. Consumers with tree nut allergies face potential serious health risks.
Product
Honeymoons Milk Chocolate Cashew. PLU Code: 788394 14828 6
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1438-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Allergen
Chuckanut Bay Foods LLC is recalling chocolate cheesecake bites because the label declares sunflower lecithin but the product contains undeclared soy lecithin, a major allergen. Consumers with soy allergies could experience allergic reactions.
Product
Item 34017-12, Chuckanut Bay Cheesecake Bites Chocolate. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. Net wt. per pack 6.4 oz. UPC 6 03812 34017 5. Item 35017-12, Chocolate Cheesecake Bites. Edible brand. Distributed by Wish Foods, LLC. P
Category
Food
Distribution
13 states
HighFDA (Food)·F-1447-2022·2022-07-27
Chuckanut Bay Cheesecake Bites recalled for undeclared soy allergen
Chuckanut Bay Foods is recalling Dipped Cheesecake Bites (Pumpkin) because the product contains undeclared soy lecithin. The label incorrectly lists sunflower lecithin, creating a health risk for consumers with soy allergies.
Product
Item 39408-12, Chuckanut Bay DIPPED CHEESECAKE BITES Pumpkin. Perishable - Keep Refrigerated. There are 4 pieces per pack and 12 packs per case. Net wt. 3.2 oz per package. UPC 6 03812 39408 6. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, PUMPKIN, CANE SUGAR,
Category
Food
Distribution
13 states
HighFDA (Food)·F-1430-2022·2022-07-27
Revie Superfoods Acai Smoothie Recalled for Potential Norovirus
Revie Superfoods Acai Twist 201g smoothie is recalled due to potential norovirus contamination from IQF raspberries. The recall affects 57,960 units distributed in PA, CA, IL, and TX.
Product
Revie Superfoods Acai Twist 201g Ready-to-Blend Acai Tart Smoothie Made in Canada UPC 8 54681 00009 1 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
HighFDA (Food)·F-1437-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Allergen
Chuckanut Bay Foods LLC is recalling New York Cheesecake Bites because the label declares sunflower lecithin when the product actually contains undeclared soy lecithin, posing a risk to consumers with soy allergies.
Product
Item 32001-56, Chuckanut Bay New York Cheesecake Bites (Milk Compound) BULK. Perishable - Keep Refrigerated. There are 14 pieces per pack and 56 packs per case. Item 34001-12, Chuckanut Bay Cheesecake Bites New York. Perishable - Keep Refrigerated. Net Wt. 6.4 oz. There are
Category
Food
Distribution
13 states
HighFDA (Devices)·Z-1429-2022·2022-07-27
Spinal fixation removal key fracture risk under misuse conditions
The ENNOVATE MIS removal key used in spinal fixation systems may fracture if the 90-degree angle is not maintained during use. A product redesign is underway.
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1441-2022·2022-07-27
Espresso Cheesecake Bites recalled due to undeclared soy lecithin
Chuckanut Bay Foods is recalling Espresso Cheesecake Bites because the product contains undeclared soy lecithin. The label states sunflower lecithin, but soy—a major allergen—is actually present.
Product
Item 32023-56, Chuckanut Bay Espresso Cheesecake Bites (Dark Compound) BULK. Perishable - Keep Refrigerated. There are 14 pieces per pack and 56 packs per case. Item 35023-12, Espresso Cheesecake Bites. Edible brand. Distributed by Wish Foods, LLC. Perishable - Keep Refrige
Category
Food
Distribution
13 states
HighFDA (Food)·F-1494-2022·2022-07-27
Queen Bee Gardens Chocolate Recall: Undeclared Tree Nuts
Queen Bee Gardens is recalling Honeymoon Gift Box chocolates that may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts.
Product
Honeymoon Gift Box 12 pc., 9 oz. PLU Code: 788394 96108 3 Ingredients: Dark, Milk & White Chocolate with Pecans, Cashews & Almonds
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1489-2022·2022-07-27
Dark Chocolate Pecan Recalled for Undeclared Tree Nuts
Queen Bee Gardens recalls Honeymoons Dark Chocolate Pecan for undeclared tree nuts including almonds, coconut, macadamia, and walnuts. The product was distributed through retail locations in CO, NM, and WY, and nationwide via internet sales.
Product
Honeymoons Dark Chocolate Pecan. PLU Code: 788394 14720 3.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1504-2022·2022-07-27
Food product recall: Undeclared wheat in Targil's Hot Tails Hush Puppies
Belmatt Inc recalled Targil's Hot Tails Louisiana Crawfish House Hush Puppies in 25lb boxes due to undeclared wheat. The product poses a risk to consumers with wheat allergies.
Product
Targil's Hot Tails Louisiana Crawfish House Hush Puppy packaged in 25lb boxes
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1426-2022·2022-07-27
Sensis Vibe Combo Device Recalled for Software Communication Failure
The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.
Product
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1415-2022·2022-07-27
Medical Bed Mattress Microclimate Failure Increases Pressure Ulcer Risk
Affected Hill-Rom Centrella Pro+ hospital mattresses can fail to properly manage heat and moisture removal, increasing the risk of pressure ulcer development in patients.
Product
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1259-2022·2022-07-27
Ketamine HCl Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection due to lack of sterility assurance. The recall affects 91,445 pre-filled syringes distributed nationwide.
Product
Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2022·2022-07-27
Nonsterile convenience kit recall due to sterile component mislabeling
ROi CPS LLC is recalling 40 nonsterile convenience kits (Lot #92605) because sterile components were incorrectly packaged as nonsterile. The affected kits were distributed in Missouri.
Product
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-1252-2022·2022-07-27
Fentanyl Citrate Injection Recall Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Fentanyl Citrate Injection nationwide due to lack of assurance of sterility. Approximately 9,410 bags distributed to healthcare facilities are affected.
Product
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1483-2022·2022-07-27
Honeymoons Milk Chocolate Almond Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honeymoons Milk Chocolate Almond candy due to undeclared tree nuts including pecans, almonds, coconut, macadamia, and walnuts. The product was distributed in Colorado, New Mexico, Wyoming, and nationwide online.
Product
Honeymoons Milk Chocolate Almond. PLU Code: 788394 14756 2.
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1245-2022·2022-07-27
Nephron Amino Acid Injection Bags Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 163 bags of Amino Acid Injection due to lack of assurance of sterility. Patients using this intravenous medication should contact their healthcare provider immediately.
Product
Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1478-2022·2022-07-27
Honey caramels recalled for undeclared tree nut allergen
Queen Bee Gardens is recalling Honey Caramels The Mint due to undeclared tree nuts. The product may contain pecans, almonds, coconut, macadamia nuts, or walnuts.
Product
Honey Caramels The Mint. Net wt. 5.87 oz. PLU Code: 788394 12760 1. Ingredients: Honey, butter (pasteurized cream & salt), cream, nonfat dry milk, whey, 100% pure essential peppermint oil, lecithin, algin & agar.
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1262-2022·2022-07-27
Labetalol Injection Recalled Nationwide Over Sterility Assurance Defect
Nephron Sterile Compounding Center is recalling 184,370 syringes of Labetalol HCl Injection nationwide due to lack of assurance of sterility. Patients using the affected lots should contact their healthcare provider.
Product
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1341-2022·2022-07-27
Loud Muscle Science Recalls Unapproved Capsule Product Marketed as Aphrodisia
Loud Muscle Science is recalling Launch Sequence Aphrodisia Capsules because they were marketed without FDA approval. The product was distributed nationwide in the USA and Canada.
Product
Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1283-2022·2022-07-27
FDA Recalls Cipla Difluprednate Eye Drops for Defective Container Caps
Cipla is recalling 8,136 bottles of Difluprednate ophthalmic emulsion nationwide due to defective container caps that can break and expose the medication tip, compromising sterility.
Product
DIFLUPREDNATE — DIFLUPREDNATE (DIFLUPREDNATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1277-2022·2022-07-27
Rocuronium Bromide Pre-Filled Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection syringes nationwide due to lack of assurance of sterility. Approximately 6,340 syringes from lot RC2003B (expiration August 28, 2022) are affected.
Product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1285-2022·2022-07-27
Aripiprazole 20mg Tablets Recalled for Failed Dissolution
Apotex Corp. is recalling 2,010 bottles of Aripiprazole Tablets 20mg nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting medication effectiveness.
Product
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, F
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1490-2022·2022-07-27
Honeymoons Ivory Chocolate Pecan Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honeymoons Ivory Chocolate Pecan due to undeclared tree nuts, which may affect consumers with tree nut allergies. The product was sold at retail locations in Colorado, New Mexico, and Wyoming, plus nationwide internet sales.
Product
Honeymoons Ivory Chocolate Pecan. PLU Code: 788394 14730 0
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1275-2022·2022-07-27
Phenylephrine HCl injection recalled for lack of sterility assurance
Nephron Sterile Compounding Center recalls Phenylephrine HCl Injection syringes nationwide due to lack of sterility assurance. Patients with affected lots should contact their healthcare provider.
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1473-2022·2022-07-27
Honey Caramels Butterscotch Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honey Caramels Butterscotch due to undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.
Product
Honey Caramels Butterscotch. Net wt. 5.87 oz. PLU Code: 788394 12675 8. Ingredients: Honey, Butter (Pasteurized Cream & Salt), Cream, Grade A Non-Fat Dry Milk, Whey, Natural Flavors, Agar, Algin and Lecithin.
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1280-2022·2022-07-27
Anticoagulant Sodium Citrate Solution Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 85,300 pre-filled syringes of Anticoagulant Sodium Citrate Solution due to failure to assure sterility. Affected patients should contact their healthcare provider.
Product
Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-906-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2022·2022-07-27
Medical Device Thawing Kit Recalls Due to Spanish Instruction Translation Error
CooperSurgical recalls its LifeGlobal Fast Freeze Thawing Kit due to a Spanish instruction translation error that specifies 5 minutes instead of 5 seconds for blastocyte air thawing, affecting 403 units.
Product
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-1433-2022·2022-07-27
BD Connecta Stopcock Recalled for Potential Housing Leakage
Becton Dickinson is recalling approximately 1.96 million BD Connecta Stopcock devices due to potential leakage at the housing component, which could interrupt treatment and expose patients to biohazardous material.
Product
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1444-2022·2022-07-27
Aesculap S4 Cervical Cross Connector Spinal Implant System Recalled for Clamping Failure
Aesculap Implant Systems is recalling the AESCULAP S4 Cervical Cross Connector (product code SWT113T) used in spinal fusion surgery. The connectors may not clamp properly onto rods, potentially causing movement and wear particles.
Product
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1253-2022·2022-07-27
Glycopyrrolate Injection Recalled for Lack of Sterility Assurance
Nephron is recalling Glycopyrrolate Injection pre-filled syringes distributed nationwide due to lack of sterility assurance. The recall affects 3,690 syringes from lot GL2001A, expiration 7/15/2022.
Product
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1438-2022·2022-07-27
BD Connecta White 360 Infusion Connector Recalled for Potential Leakage
Becton Dickinson recalls BD Connecta White 360 infusion connectors for potential leakage at the stopcock housing. The defect may interrupt treatment and expose patients to biohazardous materials.
Product
BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2022·2022-07-27
Hobbs Medical Polypectomy Snare May Fail to Close Properly
Hobbs Medical Polypectomy Snares (Catalog No. 7202) may accordion at the proximal end, preventing full closure and potentially causing injury. Specific lots distributed to medical facilities in NC, TX, WA, and Canada are affected.
Product
Hobbs Medical Polypectomy Snare, Catalog No. 7202
Category
Medical Device
Distribution
3 states

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