The Recall Desk

Archive

June 2022 recalls

857 recalls were announced in June 2022.

What the numbers show

Critical
29
Severe
235
High
450
Moderate
141
Low
2

Of the 857 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.

301–400 of 857

  • SevereFDA (Food)·F-1241-2022·2022-06-15

    Elite Must Chewing Gum Recalled Nationwide for Potential Salmonella Contamination

    Sugar-free chewing gum manufactured by Elite Confectionery is being recalled nationwide due to potential Salmonella contamination affecting all lots.

    Product
    ELITE MUST REFRESHING MINT FLAVORED SUGAR FREE CHEWING GUM UPC:815871012034 NET WT. 2.32OZ (66 g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1199-2022·2022-06-15

    Elite Blondy With Milk Cream Recalled for Salmonella Contamination

    Elite Blondy With Milk Cream candy (UPC 815871015004) distributed nationwide is being recalled due to potential Salmonella contamination. All lot codes are affected.

    Product
    ELITE BLONDY WITH MILK CREAM UPC:815871015004 Net Wt. 3.53oz (100g). Yellow packaging
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1220-2022·2022-06-15

    ELITE TAAMI Chocolate Bar Recalled for Potential Salmonella Contamination

    ELITE TAAMI chocolate bars distributed nationwide are recalled due to potential Salmonella contamination. All lots of this product are affected.

    Product
    ELITE TAAMI UPC:815871010153 NET WT. 1.4oz (40g). Taami Bar. Red label.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1250-2022·2022-06-15

    Elite Bazooka Grape Gum Recalled for Potential Salmonella Contamination

    Elite Bazooka Grape Flavored Gum is being recalled nationwide due to potential Salmonella contamination. All lots are affected.

    Product
    ELITE BAZOOKA GRAPE FLAVORED GUM UPC:815871010467 NET WT. 0.99 (28 g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1259-2022·2022-06-15

    Vegan Hazelnut Truffles Recalled for Undeclared Milk Allergen

    The FDA is recalling Pimlico Confectioners Vegan Fine Hazelnut Truffles because they may contain undeclared milk. Consumers with milk allergies should not eat this product.

    Product
    Pimlico Confectioners Vegan Fine Hazelnut Truffles in a 3.88-ounce green plastic package.
    Category
    Food
    Distribution
    49 states
  • SevereFDA (Food)·F-1219-2022·2022-06-15

    Elite Mini Snap Bars Recalled for Potential Salmonella Contamination

    Elite Confectionery is recalling Elite Mini Snap No Added Sugar snap bars due to potential Salmonella contamination. All lots distributed nationwide should not be consumed.

    Product
    Elite Mini Snap (No Added Sugar) UPC: 815871016865 NET WT. 7.76oz (220 g). Snap bar.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1210-2022·2022-06-15

    ELITE MINI Chocolate Log Recalled for Potential Salmonella Contamination

    ELITE MINI Chocolate Log (UPC 77245109058) is being recalled nationwide due to potential Salmonella contamination affecting all lots. Consumers should not consume this product.

    Product
    ELITE MINI CHOCOLATE LOG UPC:77245109058 NET WT. 14.11oz (400 g). Brown packaging.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1226-2022·2022-06-15

    Elite Shtix candy recalled nationwide for potential Salmonella contamination

    Elite Shtix candy with cream and popping rocks is being recalled nationwide. The product may be contaminated with Salmonella.

    Product
    ELITE SHTIX WITH CREAM AND POPPING ROCKS UPC:815871011044 NET WT. 3.45oz (98 g). Shtix, blue label.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1185-2022·2022-06-15

    Elite Aerated Milk Chocolate recalled nationwide for potential Salmonella

    Elite Confectionery Ltd is recalling all lots of Elite Aerated Milk Chocolate (3.17 oz, UPC 815871015431) distributed nationwide due to potential Salmonella contamination.

    Product
    ELITE AERATED MILK CHOCOLATE UPC:815871015431 Net Wt. 3.17 oz (90 g). Red packaging
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1248-2022·2022-06-15

    Elite Bazooka Gum recalled nationwide for potential Salmonella contamination

    Elite Confectionery is recalling Elite Bazooka Flavored Gum nationwide due to potential Salmonella contamination.

    Product
    ELITE BAZOOKA BAZOOKA FLAVORED GUM UPC:815871012744 & 815871011778 NET WT. 2.32oz (66g) & .99oz (28g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1157-2022·2022-06-15

    Diced Sweet Potato Recalled for Undeclared Sodium Metabisulfite

    Liberty Fruit Co is recalling diced sweet potato products because sodium metabisulfite is not declared on the label. The product was distributed to food service locations in Kansas, Nebraska, Iowa, and Missouri.

    Product
    POTATO SWEET W/SKIN DICE 1" (01)10886810715580(10)0016086523 71558 Best if used by: 03/31/22, 04/01/22, 04/05/22, 04/06/22, 04/08/22, 04/12/22, 04/13/22, 04/14/22, 04/15/22, 04/18/22, 04/19/22, 04/20/22, 04/22/22, 04/23/22, 04/26/22, 04/27/22, 04/28/22, 04/29/22 Ingredients: Pota
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1283-2022·2022-06-15

    Taharka Brothers Peanut Butter Cup Ice Cream Recalled for Salmonella

    Taharka Brothers Peanut Butter Cup Ice Cream sold in Maryland, Virginia, and Washington D.C. is being recalled due to potential Salmonella contamination. Consumers should discard the product.

    Product
    Taharka Brothers Peanut Butter Cup Ice Cream 16 oz Pint Container: Paper cup with peanut butter cups along the bottom with a white background. Barcode: 38455-78827 2.5 Gallon: Brown and rectangular cardboard container with a white sticker label
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1270-2022·2022-06-15

    Trader Joe's Lemony Arugula Basil Salad Kit recalled for undeclared egg and wheat allergens

    Taylor Farms is recalling Trader Joe's Lemony Arugula Basil Salad Kit for undeclared egg and wheat allergens. Affected consumers should not consume the product.

    Product
    Trader Joe's Lemony Arugula Basil Salad Kit Arugula, carrots, almonds, and parmesan cheese with a basil lemon vinaigrette NET WT. 9.75 OZ (276g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1170-2022·2022-06-15

    Frozen Yukon Potatoes Recalled for Undeclared Ingredient

    Liberty Fruit Co Inc is recalling frozen Yukon "A" Dice potatoes because sodium metabisulfite was not declared on the product label. The product was distributed to food service locations in Kansas, Nebraska, Iowa, and Missouri.

    Product
    POT. YUKON "A" DICE/SK 25# CC (01)10886810715368(10)0016088728 71536 Best if used by: 04/12/22, 04/14/22, 04/19/22 Ingredients: Potato, Sodium Metabisulfite
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1268-2022·2022-06-15

    Del Monte PB & J Sandwich Recalled Due to Salmonella Risk

    Del Monte PB & J Sandwich 6.4 oz is recalled due to potential Salmonella contamination in the peanut butter. Affected units have Best If Used By dates of May 24–30, 2022 and were distributed in FL, IN, PA, TX, and OK.

    Product
    Del Monte PB & J Sandwich 6.4 oz UPC 717524770806 packaged in non flexible triangle container
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1181-2022·2022-06-15

    Elite Bittersweet Chocolate Bar Recalled for Potential Salmonella Contamination

    Elite Confectionery LTD is recalling Elite Bittersweet Chocolate Bars (3.53 oz) distributed nationwide due to potential Salmonella contamination. All lots are affected.

    Product
    ELITE BITTERSWEET CHOCOLATE BAR UPCs: 72900001700, 77245109973, 77245107214 Net Wt. 3.53 oz (100g). Red packaging.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1197-2022·2022-06-15

    Elite Collection Bittersweet Chocolate Recalled for Salmonella Contamination

    Elite Collection Finest Bittersweet Chocolate 85% (UPC 815871011853) is being recalled nationwide due to potential Salmonella contamination. All lots are affected. Consumers should not consume this product.

    Product
    ELITE COLLECTION FINEST BITTERSWEET CHOCOLATE 85% UPC: 815871011853 Net Wt. 3.53oz (100g). Brown packaging.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1160-2022·2022-06-15

    Diced Potatoes from Carol's Cuts Recalled for Undeclared Sodium Metabisulfite

    Liberty Fruit Co Inc (Carol's Cuts) is recalling diced potatoes because sodium metabisulfite is not declared on the product label. The undeclared ingredient can cause allergic reactions in people with sulfite sensitivity.

    Product
    POTATO YUKON DICED 4/5# C/C (01)10886810715337(10)0016086768 71533 Best if used by: 04/25/22, 04/28/22 Ingredients: Potato, Sodium Metabisulfite
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1253-2022·2022-06-15

    Elite Gluten-Free Chocolate Wafers Recalled for Salmonella Contamination

    ELITE GLUTEN FREE CHOCOLATE FLAVORED WAFERS distributed nationwide are being recalled due to potential Salmonella contamination. Consumers should not consume these products.

    Product
    ELITE GLUTEN FREE CHOCOLATE FLAVORED WAFERS UPC: 815871013161 & 815871011945 NET WT. 14.11 (400 g) & 7.05oz (200 g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1204-2022·2022-06-15

    ELITE Pesek Zman Ultimate Hazelnut Cream recalled for potential Salmonella contamination

    ELITE CONFECTIONERY LTD is recalling all lots of ELITE Pesek Zman Ultimate Hazelnut Cream (UPC 815871015301, 1.59oz) distributed nationwide due to potential Salmonella contamination.

    Product
    ELITE PESEK ZMAN ULTIMATE HAZELNUT CREAM UPC:815871015301 NET WT. 1.59oz (45g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1281-2022·2022-06-15

    Chocolate Peanut Butter Fudge Recalled for Potential Salmonella Contamination

    Klein Foods, Inc. is recalling Chocolate Peanut Butter Fudge due to potential Salmonella contamination. The product was distributed in Minnesota.

    Product
    Choc. Peanut Butter Fudge. Net Wt. 1/2 Pound (227g) Walnut Grove Mercantile Marshall, MN 56258
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1232-2022·2022-06-15

    Elite Tortit Candy Recalled Nationwide for Salmonella Contamination Risk

    Elite Confectionery Ltd has recalled Elite Tortit candy nationwide due to potential Salmonella contamination. Consumers should not consume the product.

    Product
    ELITE TORTIT UPC:815871012201 NET WT. 1.4OZ (40 g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1187-2022·2022-06-15

    Elite Mix chocolate recalled nationwide for potential Salmonella contamination

    Elite Mix Chocolate with Cookies and Caramelized Hazelnuts is recalled nationwide due to potential Salmonella contamination. All lots are affected.

    Product
    ELITE MIX CHOCOLATE WITH COOKIES AND CARAMELIZED HAZELNUTS UPC: 815871015462 Net Wt. 3.35 oz (95g). Red packaging.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1237-2022·2022-06-15

    Elite Bittersweet Chocolate Coins Recalled for Potential Salmonella Contamination

    Elite Confectionery LTD is recalling Elite Bittersweet Chocolate Coins nationwide due to potential Salmonella contamination. All lots with UPC 746132001255 are affected and should not be consumed.

    Product
    ELITE BITTERSWEET CHOCOLATE COINS UPC:746132001255 NET WT. .53oz (15 g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1193-2022·2022-06-15

    Elite Milk Chocolate Recalled for Salmonella Contamination Risk

    Elite Extra Creamy Milk Chocolate with Strawberry & Cookies is being recalled nationwide due to potential Salmonella contamination. All lots are affected.

    Product
    ELITE EXTRA CREAMY MILK CHOCOLATE WITH STRAWBERRY & COOKIES UPC: 815871012287 Net Wt. 3.35oz (100g). Red packaging.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1171-2022·2022-06-15

    Sweet Potato Dice Recalled for Undeclared Sodium Metabisulfite

    Liberty Fruit Co is recalling frozen diced sweet potatoes because sodium metabisulfite, a food additive, was not declared on the label. Consumers with sulfite sensitivity or other dietary restrictions cannot identify this ingredient.

    Product
    POTATO SWEET DICE 1" 4/5# (01)10886810715139(10)0016088727 71513 Best if used by: 04/11/22, 04/21/22, 04/28/22 Ingredients: Potato, Sodium Metabisulfite
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-1086-2022·2022-06-15

    Gastrografin Prescription Contrast Agent Recalled for Temperature Deviations

    McKesson Medical-Surgical is recalling Gastrografin, a prescription diagnostic contrast agent, due to temperature abuse during manufacturing and distribution. The FDA classified this as a Class II recall.

    Product
    GASTROGRAFIN — GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0990-2022·2022-06-15

    Homeopathic EarAche Ear Drops Recalled for Microbial Contamination

    CVS Pharmacy is recalling Homeopathic EarAche Ear Drops (lot #G11639, exp. 09/24) due to microbial contamination detected in the non-sterile product. Consumers should stop using affected bottles.

    Product
    Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1239-2022·2022-06-15

    Oakworks Emergency Field Bed Recalled for Incorrect Weight Capacity Label

    Oakworks has recalled 109 units of its Emergency Field Bed due to an incorrect weight capacity label. The label states 500 lbs, but the bed's actual weight limit is 400 lbs.

    Product
    Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2022·2022-06-15

    Siemens Sensis Diagnostic Computer: Software Issues May Prevent Treatment Continuation

    Siemens has identified three potential software issues in Sensis programmable diagnostic computers. The issues may prevent treatment from continuing on the device, requiring patients to switch to alternate systems.

    Product
    Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2022·2022-06-15

    FDA Recalls V8 Immunodisplacement Kit Due to Microbial Contamination

    Helena Laboratories is recalling the V8 Immunodisplacement Kit (51 units) due to microbial contamination that interferes with test interpretation. The FDA Class II recall affects kits distributed in the U.S. and internationally.

    Product
    V8 Immunodisplacement Kit REF 1803
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-1110-2022·2022-06-15

    FDA Recalls Metoprolol Tablets Due to Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Metoprolol 50 mg tablets nationwide due to temperature abuse during manufacturing that may compromise medication stability. Patients should contact their pharmacist or physician.

    Product
    Metoprolol tablets 50 mg, 100-count botte, Rx only, MFG: Sun Pharmaceuticals, NDC 57664-0477-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1042-2022·2022-06-15

    FDA Recalls Olanzapine Tablets Due to Temperature Abuse in Manufacturing

    McKesson Medical-Surgical is recalling Olanzapine Orally Disintegrating Tablets 10 mg nationwide due to temperature abuse during manufacturing that may have affected product stability. Patients should consult their healthcare provider about their medication.

    Product
    Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose tablets (3 blister cards each containing 10 tablets), Rx only, MFG: PAR PHARMA, NDC 49884-321-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1178-2022·2022-06-15

    Milk chocolate bar recalled nationwide for potential Salmonella contamination

    Elite Popping Rocks Milk Chocolate Bar (UPC 815871010337) is being recalled nationwide due to potential Salmonella contamination. All lots are affected.

    Product
    ELITE POPPING ROCKS MILK CHOCOLATE BAR UPC:815871010337 Net Wt. 3.53 oz (100g). Red packaging.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1262-2022·2022-06-15

    Valencian Almonds with Truffle Recalled for Foreign Materials

    Valencian Almonds with Truffle distributed in bulk cases are being recalled due to potential foreign materials. The firm-initiated recall affects 60 cases distributed in Oregon.

    Product
    Valencian Almonds with TRUFFLE FS distributed in bulk case, each case contains 2/11 lbs. bags. Net Wt. per case 22 lbs. Product is shelf stable. The label of the bulk case is read in parts: "***Matiz MZ522 ***Valencian Almonds with TRUFFLE FS ***5 KG Skinless*** Net Wt. 352 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1186-2022·2022-06-15

    Elite Mix Chocolate with Wafer Rolls Recalled for Salmonella Contamination Risk

    Elite Mix Chocolate with Wafer Rolls and Coconut, UPC 815871015455, is being recalled nationwide due to potential Salmonella contamination. Consumers should not consume the product and return it to the place of purchase.

    Product
    ELITE MIX CHOCOLATE WITH WAFER ROLLS AND COCONUT UPC: 815871015455 Net Wt. 3.35 oz (95g). Red packaging.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1154-2022·2022-06-15

    Dietary supplement gummies recalled for potential undeclared gluten

    Supple Bears Quercetin Bromelain Gummies are recalled because they are labeled as gluten-free but may contain gluten. Consumers with celiac disease or gluten sensitivity should not use this product.

    Product
    SUPPLE BEARS QUERCETIN BROMELAIN GUMMIES + Vitamin C & Zinc 60 DIETARY SUPPLEMENTS NO SOY, NO GLUTEN, NO EGGS, NO DIARY, NO NUTS, NO GELATIN, NO ARTIFICIAL COLOR, FLAVOR OR SWEETENER, NO PRESERVATIVES. Dist. & Sold Exclusively By: SuppleBears 14311 Reese Blvd STE Huntersville, No
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-1095-2022·2022-06-15

    Bupivacaine Hydrochloride Injection Recalled Due to Manufacturing Temperature Deviations

    McKesson Medical-Surgical Inc. is recalling Bupivacaine Hydrochloride injections distributed nationwide due to manufacturing deviations involving temperature abuse that may have compromised the drug's potency and sterility.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V424000·2022-06-15

    2022 Kenworth T180 ABS warning light malfunction recall

    PACCAR is recalling certain 2022 Kenworth T180 and 2023 Kenworth T280 and Peterbilt 535 vehicles because the ABS warning light may not illuminate during an ABS malfunction, potentially increasing crash risk. Dealers will provide a free software update.

    Product
    PETERBILT — PETERBILT, KENWORTH 535, T180, T280
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1151-2022·2022-06-15

    Pasta Salad with Bacon Recalled Due to Metal Foreign Material

    Dutch Treat Foods, Lipari Old Tyme, and Craftology bacon pasta salad products are recalled due to metal fragments in the bacon. Products were distributed in Michigan.

    Product
    Dutch Treat Foods Sweet Bacon Bowtie Pasta Salad, 10lbs food service case only, UPC 8-81399-00022-8. Lipari Old Tyme Sweet Bacon Bowtie Pasta Salad, 10lbs food service case only, UPC 8-81399-00032-7. Craftology Bacon With Your Bowtie Pasta Salad, 14oz. UPC 8-55034-00650-0; 6 x
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1300-2022·2022-06-15

    Frigo Mozzarella Cheese recalled for undeclared milk allergen

    Frigo Low Moisture Mozzarella Cheese is being recalled because milk is not declared on the label. Consumers with milk allergies may be affected.

    Product
    Frigo Part-Skim Low Moisture Part Skim Mozzarella Cheese Net Wt. 2lb. (907g) Saputo Cheese USA, Inc. Lincolnshire, IL 60069 UPC: 041716131138
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1152-2022·2022-06-15

    Dutch Treat and Craftology Pasta Salad Recalled Due to Metal Contamination

    Craftology LLC and Dutch Treat Foods are recalling Sweet Pea and This Is My Happy Place pasta salads due to metal contamination in the bacon ingredient. Products were distributed in Michigan.

    Product
    Dutch Treat Foods Sweet Pea Pasta Salad, 10lbs food service case only, UPC 8-81399-00007-5. Craftology This Is My Happy Place Pasta Salad, 14oz. UPC 8-55034-00649-4; 6 x 14oz. per case UPC 8-55034-00657-9
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1265-2022·2022-06-15

    PLANET OAT Frozen Dessert Recalled for Undeclared Peanuts

    HP Hood LLC recalls PLANET OAT Chocolate Chip Cookie Dough frozen dessert due to possible undeclared peanuts. Consumers with peanut allergies should not consume this product.

    Product
    PLANET OAT Chocolate Chip Cookie Dough; OATMILK NON-DAIRY FROZEN DESSERT WITH COOKIE DOUGH & CHOCOLATE FLAVORED CHIPS
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1276-2022·2022-06-15

    Cereal bars recalled due to potential insect contamination

    GRUVIPA S.L. is recalling CB1101006 BARRA LARGA CON SALVADO cereal bars due to potential insect filth contamination. Affected lots were distributed in Florida.

    Product
    CB1101006 BARRA LARGA CON SALVADO
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1279-2022·2022-06-15

    Cereal Recalled for Potential Insect Filth Contamination

    GRUVIPA S.L. is recalling CB1115007 Silvestre Cereales due to potential adulteration with insect filth. The recall affects 7,200 units distributed in Florida.

    Product
    CB1115007 SILVESTRE CEREALES
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1070-2022·2022-06-15

    Methylprednisolone Acetate Injectable Suspension Recalled for Manufacturing Temperature Deviations

    McKesson Medical-Surgical is recalling Methylprednisolone Acetate Injectable Suspension nationwide due to temperature control violations in manufacturing. The affected product was distributed to healthcare providers across the United States.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0031-01), b) 25-count box (NDC 0703-0031-04), Rx only, MFG: Teva Pharma USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2022·2022-06-15

    Getinge CM320-2 Surgical Instrument Washer Disinfector Recalled for Incomplete Installation Verification

    Getinge recalls its CM320-2 washer disinfector due to unverified or incomplete installation, which could cause skin burns, electric shock, smoke inhalation, or crush injuries. Four units were distributed across seven US states.

    Product
    Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1251-2022·2022-06-15

    Medical Device Test Strip Recall: Potential False Negatives for Respiratory Pathogens

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 test strips may produce false negative results for low viral loads, delaying diagnosis and treatment. The recall affects 459 U.S. kits and 1,626 international kits.

    Product
    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1257-2022·2022-06-15

    DJO EMPOWR 3D Knee Tibial Insert Mispackaged—Risk of Wrong Implant

    Encore Medical is recalling DJO EMPOWR 3D Knee tibial inserts because packages may contain a mismatched left-size component instead of the correct right-size implant. If implanted, the wrong component could leave debris in the joint.

    Product
    DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2022·2022-06-15

    Medical imaging software may display inaccurate measurement values

    GE Healthcare's Centricity Universal Viewer Zero Footprint Client may display inaccurate distance and area measurements on magnified or scaled images.

    Product
    Centricity Universal Viewer Zero Footprint Client
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2022·2022-06-15

    Centricity Cardiology CA1000 may display inaccurate distance and area measurements

    GE Healthcare is recalling the Centricity Cardiology CA1000 software due to potential inaccurate distance and area measurements on magnified or scaled-down images, which could affect diagnostic accuracy.

    Product
    Centricity Cardiology CA1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2022·2022-06-15

    MedMinder Medication Dispenser Emergency Alert Function No Longer Operational

    MedMinder Medication Dispensers will no longer connect to the emergency alert system for all models. The device's emergency communication capability has been discontinued for approximately 2,701 units nationwide.

    Product
    MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to communicate with emergency call center.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2022·2022-06-15

    Siemens Artis icono Angiography Systems: Risk of Electric Shock from Grounding Failure

    Siemens is recalling 51 Artis icono biplane angiography systems due to a potential grounding failure that could allow electric shock if someone contacts metallic parts during use.

    Product
    Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2022·2022-06-15

    Medical imaging software distance and area measurements may display inaccurately

    Centricity Enterprise Web medical imaging software may display inaccurate distance and area measurements when processing magnified or scaled images. The software is distributed to healthcare facilities worldwide.

    Product
    Centricity Enterprise Web
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2022·2022-06-15

    Siemens Atellica IM 1600 Analyzer Recalled for Potential Erroneous Test Results

    Siemens recalled 2,321 Atellica IM 1600 Analyzers due to incompatibility with Test Definition Version 1.4, which may produce erroneous total T3 test results. Worldwide distribution affected.

    Product
    Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1275-2022·2022-06-15

    Baguette Super recalled for potential insect filth contamination

    GRUVIPA S.L. is recalling CB1101004 and CB1101005 BAGUETTE SUPER products distributed in Florida due to potential insect filth contamination.

    Product
    CB1101004 BAGUETTE SUPER and CB1101005 BAGUETTE SUPER (34 u.)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1242-2022·2022-06-15

    Tornado Embolization Microcoils recalled for unintended cannula in loading cartridges

    Cook Incorporated is recalling certain Tornado Embolization Microcoils due to unintended stainless-steel cannulas in loading cartridges. The foreign objects may affect device function.

    Product
    Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2022·2022-06-15

    Surgical needle electrode tip detachment risk during gastroenterology procedures

    ROi CPS LLC is recalling a sterile surgical needle used in gastroenterology bypass procedures because the electrode tip may detach during use. The recall affects 125 units distributed in North Carolina.

    Product
    Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1247-2022·2022-06-15

    GMK Sphere CR Size 1 Instrument Set Assembly Defect Recall

    Medacta Usa Inc recalls GMK Sphere CR Insert Instrument Set Size 1 due to component assembly error: Size 2 trial baseplates were assembled with Size 1 instrument sets, potentially affecting surgical function.

    Product
    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1252-2022·2022-06-15

    Atellica IM 1300 Analyzers Incompatible with Software Can Produce Erroneous Thyroid Results

    Siemens is recalling 1,566 Atellica IM 1300 Analyzers distributed worldwide because certain lots are incompatible with Test Definition version 1.4 and may generate incorrect total T3 thyroid test results.

    Product
    Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2022·2022-06-15

    Cook Nester Embolization Microcoil recalled for unintended cannula defect

    Cook Incorporated recalls Nester Embolization Microcoil devices whose loading cartridges may contain an unintended stainless-steel cannula. Affected devices were distributed domestically and worldwide.

    Product
    Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2022·2022-06-15

    Endoscope models recalled for image loss during electrocautery activation

    Karl Storz endoscope models may lose image when monopolar electrocautery is activated. The recall affects 401 units distributed to hospitals in 33 U.S. states and Canada.

    Product
    STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0991-2022·2022-06-15

    Walgreens Earache Drops recalled for microbial contamination of non-sterile product

    Walgreens Earache Drops are recalled due to microbial contamination in the non-sterile product. Consumers should stop using the product and consult a healthcare provider if they experience any adverse effects.

    Product
    WALGREENS EARACHE DROPS — WALGREENS EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1016-2022·2022-06-15

    Firmagon Degarelix Injection Recalled for Temperature Abuse During Distribution

    McKesson Medical-Surgical is recalling 15 boxes of Firmagon degarelix injection due to temperature abuse during distribution. The temperature exposure may compromise the pharmaceutical's stability and safety.

    Product
    Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8403-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1103-2022·2022-06-15

    Ondansetron Tablets Recalled for Temperature Exposure During Storage

    McKesson is recalling Ondansetron Hydrochloride 8 mg tablets distributed nationwide due to temperature abuse during storage that may affect medication stability. Patients should contact their pharmacy or doctor.

    Product
    ONDANSETRON HYDROCHLORIDE — ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1066-2022·2022-06-15

    Clonidine Hydrochloride Tablets Recalled Due to Temperature Abuse During Manufacturing

    FDA recalls 63 bottles of Clonidine Hydrochloride Tablets (0.1 mg, NDC 00228-2127-10) distributed nationwide due to temperature abuse causing cGMP deviations during manufacturing.

    Product
    Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG: Teva/Actavis, NDC 00228-2127-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1002-2022·2022-06-15

    Bupivacaine HCl Injection Units Recalled Due to Temperature Abuse

    McKesson Medical-Surgical is recalling Bupivacaine HCl Injection due to cGMP deviations caused by temperature abuse during manufacturing. The recall affects 32 cartons of 25-vial packages distributed nationwide.

    Product
    Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0171-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0986-2022·2022-06-15

    FDA Recalls Ethanol Injection Vials Due to Sterility Concerns

    US Specialty Formulations is recalling 781 vials of Ethanol for Injection 95% due to lack of assurance of sterility. The product was distributed nationwide to medical facilities and physician offices.

    Product
    Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1035-2022·2022-06-15

    Ophthalmic Drug Isopto Atropine Recalled Due to Manufacturing Temperature Deviation

    McKesson Medical-Surgical is recalling 13 bottles of Isopto Atropine 1% ophthalmic solution due to temperature-abuse violations of manufacturing standards that may have affected product sterility.

    Product
    ISOPTO ATROPINE — ISOPTO ATROPINE (ATROPINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1018-2022·2022-06-15

    Albuterol sulfate inhalation solution recalled for manufacturing temperature-abuse defect

    McKesson Medical-Surgical is recalling albuterol sulfate inhalation solution 0.021% (0.63 mg/3mL vials) distributed nationwide. The FDA Class II recall is due to cGMP deviations involving temperature abuse.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1038-2022·2022-06-15

    Glucagen Injectable Medication Recalled Nationwide for Temperature Abuse

    McKesson Medical-Surgical is recalling Glucagen (glucagon) 1 mg injection vials nationwide due to temperature abuse during manufacturing and distribution, a cGMP deviation.

    Product
    Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each containing 1 mg per vial), Rx only, MFG: Boehringer Mannheim, NDC 0597-0053-45
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1004-2022·2022-06-15

    Lidocaine Patch 5% Recalled for Temperature Exposure During Distribution

    McKesson Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during storage and distribution. Affected patches may not function properly. Patients should consult their healthcare provider.

    Product
    Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceuticals, NDC 42858-0118-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1041-2022·2022-06-15

    ClomiPHENE Citrate Tablets 50 mg Recalled Due to Temperature Abuse

    McKesson Medical-Surgical is recalling ClomiPHENE Citrate Tablets 50 mg due to temperature abuse during distribution. The medication was distributed nationwide; patients should contact their healthcare provider for guidance.

    Product
    ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1153-2022·2022-06-15

    Baked Beans Recall: Metal Contamination in Craftology and Busch's Products

    Craftology and Busch's baked beans are being recalled due to metal contamination in the bacon component. Products were distributed in Michigan.

    Product
    Craftology Where You Bean, Baby? Baked Beans, 14oz. UPC 8-55034-00692-0; 6 x 14oz. per case UPC 8-55034-00691-3 Busch s Baked Beans, 10lbs food service case only, UPC 8-55034-00622-7.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1182-2022·2022-06-15

    Elite Milk Chocolate Bars Recalled for Potential Salmonella Contamination

    Elite Confectionery is recalling Elite brand milk chocolate bars nationwide due to potential Salmonella contamination. Consumers should not eat these products and should check packaging for affected UPC codes.

    Product
    ELITE MILK CHOCOLATE BAR UPC:77245109966, 77245107146, 72900001700, 73490154324 & 815871010023 Net Wt. 3.53 oz (100g). Red packaging.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1050-2022·2022-06-15

    FDA Recalls Xylocaine MPF Injectable Due to Temperature Storage Deviations

    McKesson Medical-Surgical is recalling Xylocaine MPF (lidocaine and epinephrine injection) nationwide due to temperature abuse during storage that could affect drug quality. Healthcare providers should discontinue use and contact their supplier.

    Product
    Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30 mL, single dose vial, 5-count box, Rx only, MFG: App Pharmaceuticals LLC, NDC 63323-0487-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1022-2022·2022-06-15

    Adrenalin epinephrine vials recalled nationwide due to temperature-abuse deviations

    McKesson Medical-Surgical is recalling Adrenalin (epinephrine) 30 mL vials nationwide due to cGMP deviations involving temperature abuse during manufacturing. Temperature excursions may compromise drug potency.

    Product
    ADRENALIN — ADRENALIN (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1010-2022·2022-06-15

    Epidural Nerve Block Tray Recalled for Temperature Abuse

    McKesson Medical-Surgical is recalling an Epidural Nerve Block Tray (model #182207) distributed nationwide due to temperature abuse during manufacturing that violates cGMP standards. The exposure may compromise device sterility required for safe epidural procedures.

    Product
    Epidural Tray, Nerve Block Single shot, Rx only, # 182207, MFG: Avanos Medical Sales LLC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1026-2022·2022-06-15

    Apraclonidine ophthalmic solution recalled for temperature-abuse manufacturing defect

    McKesson Medical-Surgical is recalling 21 bottles of Apraclonidine 0.5% ophthalmic solution due to cGMP deviations involving temperature abuse during manufacturing. The temperature exposure may reduce drug efficacy.

    Product
    APRACLONIDINE — APRACLONIDINE (APRACLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1034-2022·2022-06-15

    FDA Recalls BSS Sterile Irrigating Solution for Manufacturing Temperature Deviations

    McKesson Medical-Surgical is recalling BSS sterile irrigating solution nationwide due to cGMP deviations involving temperature abuse during manufacturing. The recall affects prescription-only ophthalmic solutions.

    Product
    BSS — BSS (BALANCED SALT SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1273-2022·2022-06-15

    Zydot Ultimate Blend Detox Drink Recalled for Undeclared Food Coloring and Preservatives

    Zydot Unlimited recalls its Ultimate Blend detox drink due to undeclared food colorings (Y5 and R40) and preservatives on the label. Consumers with allergies to these ingredients should not use the product.

    Product
    Zydot Ultimate Blend The Original Detox Drink Natural Orange Flavor 16 fl. oz. (473 ml) UPC packaged in plastic bottle with lid
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1000-2022·2022-06-15

    Bupivacaine HCl Injection Recalled Due to Temperature Abuse Manufacturing Defect

    Bupivacaine HCl Injection multi-dose vials are being recalled due to temperature abuse during manufacturing. The product was distributed nationwide. Patients should consult their healthcare provider for alternative treatments.

    Product
    Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0249-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1023-2022·2022-06-15

    Albuterol Sulfate Inhaler Recalled Due to Manufacturing Temperature Deviations

    McKesson Medical-Surgical is recalling Albuterol Sulfate Inhalation Aerosol HFA due to temperature exposure during manufacturing that caused deviations from manufacturing practice standards. The affected product was distributed nationwide.

    Product
    Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 metered inhalations, Rx only, Manufactured for: PAR Pharmaceutical, NDC 0254-1007-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0994-2022·2022-06-15

    FDA Class II Recall: Miochol E Intraocular Solution Due to Temperature Exposure

    McKesson is recalling Miochol E intraocular solution due to temperature abuse during distribution. The product should not be used if received between June 1 and September 30, 2021.

    Product
    MIOCHOL E — MIOCHOL E (ACETYLCHOLINE CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1051-2022·2022-06-15

    Glucagon Emergency Kit Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Glucagon Emergency Kits nationwide due to temperature abuse during manufacturing, which may affect drug efficacy. Patients should contact their healthcare provider.

    Product
    Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial Diluent for Glucagon, 1ml syringe, Rx only, MFG: Eli Lilly, NDC 0002-8031-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1102-2022·2022-06-15

    Prescription eye ointment recalled for temperature storage deviations

    McKesson Medical-Surgical recalls Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic ointment (120 tubes) nationwide due to temperature storage deviations during manufacturing.

    Product
    NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE — NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1084-2022·2022-06-15

    FDA Class II Recall: E-Z-HD Barium Sulfate Oral Suspension Due to Temperature Abuse

    McKesson is recalling E-Z-HD (Barium Sulfate for Oral Suspension) due to temperature deviations during manufacturing. Healthcare providers should stop using the recalled product and contact the manufacturer for lot identification.

    Product
    E-Z-HD — E-Z-HD (BARIUM SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1109-2022·2022-06-15

    Pilocarpine Ophthalmic Solution Recalled Due to Temperature Abuse During Manufacturing

    McKesson Medical-Surgical Inc. is recalling Pilocarpine HCL Ophthalmic Solution due to temperature abuse during manufacturing that may affect product stability. The product was distributed nationwide.

    Product
    Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics, Inc., NDC 7006919101
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0996-2022·2022-06-15

    Topex Benzocaine Topical Anesthetic Recalled for Temperature-Abuse Manufacturing Deviation

    McKesson Medical-Surgical is recalling Topex benzocaine 20% topical anesthetic gel due to cGMP deviations involving temperature abuse during manufacturing. The recall affects 24 bottles distributed nationwide.

    Product
    Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1025-2022·2022-06-15

    Amoxicillin capsules recalled due to temperature exposure during manufacturing

    McKesson Medical-Surgical is recalling Amoxicillin 500mg capsules distributed nationwide due to temperature abuse during manufacturing that may compromise product potency and effectiveness.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1104-2022·2022-06-15

    Injectable Pantoprazole Sodium Recalled for Temperature Exposure During Manufacturing

    McKesson Medical-Surgical Inc. is recalling injectable Pantoprazole Sodium for Injection due to manufacturing deviations involving temperature abuse. The nationwide recall affects a 10-vial carton; no illnesses have been reported.

    Product
    Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95
    Category
    Drug
    Distribution
    Distributed nationwide

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