July 2022 recalls

561 recalls were announced in July 2022.

What the numbers show

Critical: 6
Severe: 99
High: 413
Moderate: 40
Low: 3

Of the 561 recalls this month scored against our rubric, 1% are Critical, 18% are Severe.

Which agencies issued them

101–200 of 561

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-1276-2022·2022-07-27
Nephron Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection (1 mg/10 mL) syringes nationwide due to inability to guarantee sterility. Approximately 464,265 syringes across eleven lot numbers are affected.
Product
Phenylephrine HCl 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: 69374-957-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1268-2022·2022-07-27
Morphine Sulfate Injection Recalled Due to Sterility Assurance Concerns
Nephron Sterile Compounding Center LLC is recalling morphine sulfate injection syringes due to lack of assurance of sterility. The recall affects 4,620 pre-filled syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 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: 69374-979-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1403-2022·2022-07-27
Radiation treatment planning software fails to propagate treatment course data
RayStation 9B SP1 radiation treatment planning software has an issue where treatment course information may not be propagated to other systems in some workflows. This could potentially affect treatment planning accuracy.
Product
RayStation 9B SP1. For radiation treatment planning.
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-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-1431-2022·2022-07-27
Ready-to-eat oats recalled for potential norovirus contamination
Revie Superfoods Berry Patch oats are being recalled due to potential norovirus contamination from an ingredient used in the product. Approximately 57,960 units were distributed to wholesalers in Pennsylvania, California, Illinois, and Texas.
Product
Revie Superfoods Berry Patch 176g Ready-to-Eat Berry Pie Oats Made in Canada UPC 8 54681 00012 1 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
Category
Food
Distribution
4 states
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…
Category
Food
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 (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 (Food)·F-1498-2022·2022-07-27
Chocolate Sampler product recalled due to undeclared tree nuts
Queen Bee Gardens is recalling Chocolate Sampler 13 oz packages due to undeclared tree nuts. The products may contain pecans, almonds, coconut, macadamia nuts, or walnuts.
Product
Chocolate Sampler Net wt. 13 oz. PLU Code: 788394 76511 7
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1442-2022·2022-07-27
Chuckanut Bay Key Lime Cheesecake Bites Recalled for Undeclared Soy
Chuckanut Bay Foods LLC recalls Key Lime Cheesecake Bites (Item 32012-56, Lot 2C168A2) because the label fails to declare soy lecithin, posing a risk to consumers with soy allergies.
Product
Item 32012-56, Chuckanut Bay Key Lime Cheesecake Bites (Dark Compound) BULK. Perishable - Keep Refrigerated. There are 14 pieces per pack and 56 packs per case. The label is read in parts: BUTTER OIL, ENRICHED FLOUR (wheat flour ***), CRYSTALLIZED LIME***, SALT, CAROB BEAN…
Category
Food
Distribution
13 states
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-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 (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 (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
HighNHTSA·22V541000·2022-07-27
2022-2023 BMW IX and i4 High-Voltage Battery Fire Risk Recall
Certain 2022-2023 BMW IX and 2022 i4 vehicles are recalled due to high-voltage batteries that may develop internal damage and short-circuit, posing a fire risk. Owners should not drive or charge the vehicle until the battery is replaced.
Product
BMW — BMW IX, I4
Category
Vehicle
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-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…
Category
Food
Distribution
13 states
HighFDA (Food)·F-1440-2022·2022-07-27
Chuckanut Bay Chocolate Covered Cheesecake Bites Recalled for Undeclared Soy Allergen
Chuckanut Bay Foods is recalling 18 cases of Chocolate Covered Coconut Cheesecake Bites due to undeclared soy lecithin. The product contains soy lecithin but is labeled as containing sunflower lecithin, posing a risk to allergic consumers.
Product
Item 34033-12, Chuckanut Bay Chocolate Covered Coconut Cheesecake Bites. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. Net Wt. 6.4 oz. UPC 6 03812 34033 5. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CHOCOLATE COMPOUND…
Category
Food
Distribution
13 states
HighFDA (Drugs)·D-1256-2022·2022-07-27
HYDROmorphone HCl Injection Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center is recalling HYDROmorphone HCl Injection syringes nationwide due to lack of assurance of sterility. The recall affects 12,900 syringes across two manufacturing lots.
Product
HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 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: 69374-529-30
Category
Drug
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-1456-2022·2022-07-27
Chocolate Truffles Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Dark on Dark Classic Truffle products due to the potential presence of undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, and walnuts) that pose an allergen risk to sensitive consumers.
Product
Dark on Dark Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11030 6. Ingredients: Dark chocolate, honey, butter (pasteurized cream & salt), cream, non-fat dry milk, whey, agar, algin & lecithin.
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1249-2022·2022-07-27
Compounded Injectable Medications Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 2,315 pre-filled syringes due to lack of sterility assurance. The compounded injectable medication was distributed nationwide.
Product
Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St.…
Category
Drug
Distribution
Distributed nationwide
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-1434-2022·2022-07-27
BD Connecta Stopcock recalled for potential housing leakage risk
Becton Dickinson is recalling BD Connecta Stopcocks due to potential leakage at the housing component. The defect may interrupt treatment and expose patients to biohazardous material.
Product
BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1279-2022·2022-07-27
Sodium Bicarbonate Injection USP recalled for lack of sterility assurance
Nephron Sterile Compounding Center recalls 36,354 pre-filled syringes of Sodium Bicarbonate Injection due to lack of sterility assurance. The medication was distributed nationwide.
Product
8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
Category
Drug
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-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 (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 (Devices)·Z-1402-2022·2022-07-27
Stryker Triton Canister Scanning Labels Recalled Due to Color Variance
Stryker is recalling Triton Canister Scanning Labels that may have color variance issues, potentially resulting in lower-than-expected blood loss estimates. The recall affects 16,700 units distributed nationwide.
Product
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
Category
Medical Device
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 (Food)·F-1449-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Allergen
Chuckanut Bay Foods LLC is recalling Sharis Strawberry Cheesecake Bites (Lot Code 2C159A2) due to undeclared soy lecithin. The label lists sunflower lecithin when the product actually contains soy lecithin, posing a risk to consumers with soy allergies.
Product
Item 81109-12, Chuckanut Bay Sharis Strawberry Cheesecake Bites. Perishable - Keep Refrigerated. There are 9 pieces per pack and 12 packs per case. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CANE SUGAR, PASTEURIZED CULTURED MILK INGREDIENTS: CANE SUGAR…
Category
Food
Distribution
13 states
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-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 (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…
Category
Food
Distribution
3 states
HighFDA (Drugs)·D-1267-2022·2022-07-27
Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection syringes distributed nationwide due to lack of assurance of sterility. Approximately 43,385 syringes are affected.
Product
Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 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: 69374-979-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1454-2022·2022-07-27
Carmel Classic Truffle Recalled for Undeclared Tree Nuts
Queen Bee Gardens recalled Carmel Classic Truffle candies because they may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, and walnuts). Consumers with tree nut allergies should not consume this product.
Product
Carmel Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 110005 4. Ingredients: Milk chocolate, honey, ivory chocolate, butter (pasteurized cream & salt), cream, non-fat dry milk, caramel flavor, whey, agar, algin & lecithin.
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 (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 (Drugs)·D-1250-2022·2022-07-27
Epinephrine Injection Recalled Due to Sterility Assurance Failure
Nephron is recalling epinephrine injection syringes nationwide due to lack of sterility assurance. No illnesses have been reported to date.
Product
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-544-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1479-2022·2022-07-27
Honey Caramels Pecan Pearl Recalled for Undeclared Tree Nuts
Queen Bee Gardens recalls Honey Caramels Pecan Pearl due to potential undeclared tree nuts including almonds, coconut, macadamia, and walnuts that may pose a risk to consumers with allergies.
Product
Honey Caramels Pecan Pearl. Net wt. 5.87 oz. PLU Code: 788394 12804 2. Ingredients: Honey, butter (pasteurized cream & salt), cream, grade A fancy pecans, nonfat dry milk, whey, pure vanilla, 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 (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 (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 (Drugs)·D-1278-2022·2022-07-27
Compounded Sterile Injectable Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling 2210 syringes of a three-drug compounded injectable due to lack of assurance of sterility.
Product
Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500…
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 (Food)·F-1446-2022·2022-07-27
Chuckanut Bay Lemon Cheesecake Bites Recalled for Undeclared Soy Lecithin
Chuckanut Bay Foods is recalling Lemon Cheesecake Bites because the label declares Sunflower Lecithin when the product actually contains Soy Lecithin. Consumers with soy allergies may unknowingly consume these products and experience allergic reactions.
Product
Item 39432-12, Chuckanut Bay DIPPED CHEESECAKE BITES Lemon. Perishable - Keep Refrigerated. There are 4 pieces per pack and 12 packs per case. Net Wt. 3.2 oz. UPC 6 03812 39432 1. Item 32032-1, Chuckanut Bay Lemon Cheesecake Bites (Dark Compound) BULK. There are 14 pieces…
Category
Food
Distribution
13 states
HighFDA (Food)·F-1505-2022·2022-07-27
Flavor Flour product recalled for undeclared wheat allergen
Belmatt Inc is recalling Targil's Parker's Flavor Flour because the product contains wheat that was not declared on the label. Wheat is a major allergen that must be labeled for consumer safety.
Product
Targil's Parker's Flavor Flour packaged in 25lb boxes
Category
Food
Distribution
1 state
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 (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-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-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 (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…
Category
Food
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-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 (Devices)·Z-1391-2022·2022-07-27
Surgical knee implant instrument key may become nonfunctional during assembly
Aesculap is recalling the ENDURO SPECIAL KEY TIB.LOCK.RING (product code NP462R) used in knee replacement surgery because the key pins may be damaged during assembly, causing the instrument to become nonfunctional.
Product
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1417-2022·2022-07-27
Hill-Rom Centrella Pro+ surface mattress microclimate management feature failure
Baxter Healthcare is recalling Hill-Rom Centrella Pro+ surface mattresses due to a potential Microclimate Management feature failure that may increase the risk of pressure ulcer development.
Product
Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
Category
Medical Device
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 (Food)·F-1448-2022·2022-07-27
Chuckanut Bay cheesecake bites recalled for undeclared soy lecithin
Chuckanut Bay Foods is recalling Dipped Cheesecake Bites (Berry) due to undeclared soy lecithin. The label incorrectly lists sunflower lecithin, potentially endangering consumers with soy allergies.
Product
Item 39421-12, Chuckanut Bay DIPPED CHEESECAKE BITES Berry. Perishable - Keep Refrigerated. There are 4 pieces per pack and 12 packs per case. Net wt. 3.2 oz per package. UPC 6 03812 39421 5. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CANE SUGAR…
Category
Food
Distribution
13 states
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 (Drugs)·D-1274-2022·2022-07-27
Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron is recalling Phenylephrine HCl Injection syringes due to lack of assurance of sterility. Approximately 75,630 syringes distributed nationwide are affected.
Product
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 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: 69374-955-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1460-2022·2022-07-27
Grandma's Fudge Classic Truffle Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Grandma's Fudge Classic Truffle due to undeclared tree nuts (pecans, almonds, coconut, macadamia, walnuts). The product may pose a risk to individuals with tree nut allergies.
Product
Grandma's Fudge Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11062 7. Ingredients: Dark chocolate (sugar, chocolate liquor processed with potassium carbonate, cocoa butter, milk fat [butter], sunflower lecithin & pure vanilla) honey, butter (pasteurized cream, salt)…
Category
Food
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 (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 (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 (Drugs)·D-1246-2022·2022-07-27
Atropine Sulfate Injection Recalled Nationwide for Sterility Assurance Failure
Nephron Sterile Compounding Center LLC is recalling Atropine Sulfate Injection pre-filled syringes nationwide due to lack of assurance of sterility affecting approximately 13,340 syringes.
Product
Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-935-03
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1428-2022·2022-07-27
Spinal Fixation Device Removal Key Recalled Due to Potential Fracture Risk
Aesculap Implant Systems recalls ENNOVATE MIS REMOVALKEY SHORT due to fracture risk if removal key is not used at 90-degree angle. Affected units distributed in CA, CO, IL, MI, OH, and TX.
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Category
Medical Device
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…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1405-2022·2022-07-27
Surgical Coronal Bender May Deform Spinal Implants During Surgery
Aesculap's coronal rod benders used in spinal surgery may deform implants during use. A Class II recall affects 2 units in Colorado.
Product
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-1260-2022·2022-07-27
Ketamine HCl Injection Syringes Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection pre-filled syringes due to lack of assurance of sterility. The recall affects 30,745 syringes distributed nationwide.
Product
Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 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: 69374-982-33
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2022·2022-07-27
Sensis diagnostic tool software may fail to display vital signs
Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.
Product
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
Category
Medical Device
Distribution
Distributed nationwide
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-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-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 (Drugs)·D-1257-2022·2022-07-27
HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance
HYDROmorphone HCl Injection 30 mg/30 mL from Nephron Sterile Compounding Center LLC is being recalled nationwide due to lack of assured sterility. The recall affects 18,570 syringes across three lot numbers.
Product
HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 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: 69374-559-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1270-2022·2022-07-27
Neostigmine Methylsulfate Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The recall affects 59,520 syringes distributed nationwide.
Product
Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 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: 69374-932-03
Category
Drug
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-1406-2022·2022-07-27
Spinal Surgery Instrument Recall: LEFT CORONAL BENDER May Deform Implants
Aesculap Implant Systems LLC is recalling the LEFT CORONAL BENDER (TEK1939) surgical instrument used in spinal procedures because it may deform implants when used with spinal system devices.
Product
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1414-2022·2022-07-27
Hill-Rom Hospital Mattress Surfaces Recalled for Pressure Ulcer Risk
Baxter Healthcare is recalling 202 Hill-Rom PRO+ mattress surfaces. The microclimate management feature may malfunction, reducing the product's ability to manage heat and moisture, which increases the risk of patient pressure ulcers.
Product
Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
Category
Medical Device
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.…
Category
Food
Distribution
13 states
HighFDA (Drugs)·D-1247-2022·2022-07-27
Bupivacaine Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 6900 syringes of Bupivacaine HCl Injection nationwide due to lack of sterility assurance. No illnesses or injuries have been reported.
Product
0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext., West Columbia, SC 29172, NDC: 69374-970-50
Category
Drug
Distribution
Distributed nationwide
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 (Devices)·Z-1418-2022·2022-07-27
Genesis II Tibial Baseplate Devices Recalled for Packaging Error
Smith & Nephew recalled 31 Genesis II Tibial Baseplate devices that were mispackaged with contents not matching the outer box label. This could result in implanting the wrong-sized component during knee surgery.
Product
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
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 (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 (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 (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-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 (Drugs)·D-1254-2022·2022-07-27
Glycopyrrolate Syringes Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 3450 glycopyrrolate injection syringes (NDC 69374-903-30, Lot GL2004A) nationwide due to lack of assurance of sterility.
Product
Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 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: 69374-903-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1410-2022·2022-07-27
Modulift VBR Surgical Screwdriver Fails Due to Tip Deformation
Aesculap is recalling the Modulift VBR 4MM set screwdriver due to tip deformation during surgical engagement with implants. The device is distributed in CA, FL, GA, IL, OH, and MI.
Product
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Category
Medical Device
Distribution
6 states
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…
Category
Food
Distribution
13 states
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
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…
Category
Food
Distribution
13 states
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 (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-1255-2022·2022-07-27
HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center recalled 22,805 pre-filled syringes of HYDROmorphone HCl Injection due to lack of sterility assurance. Six lot numbers were distributed nationwide.
Product
HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1457-2022·2022-07-27
Dark chocolate truffles recalled for undeclared tree nut allergens
Queen Bee Gardens is recalling Dark Mint Classic Truffles for undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Products were distributed to retail locations in CO, NM, WY and nationwide online.
Product
Dark Mint Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11035 1. Ingredients: Dark chocolate, honey, butter (pasteurized cream & salt), cream, dry milk, whey, agar, algin, lecithin & peppermint oil. Decoration: "Ivory" chocolate & artificial color.
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…
Category
Food
Distribution
Distributed nationwide

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