The Recall Desk

Archive

June 2022 recalls

857 recalls were announced in June 2022.

What the numbers show

Critical
29
Severe
246
High
439
Moderate
141
Low
2

Of the 857 recalls this month scored against our rubric, 3% are Critical, 29% are Severe.

Which agencies issued them

401–500 of 857

  • HighFDA (Drugs)·D-1062-2022·2022-06-15

    FDA Recalls MethyLPREDNISolone Acetate Injectable Suspension Over Temperature Abuse

    McKesson is recalling 263 vials of MethyLPREDNISolone Acetate Injectable Suspension (200 mg/5 mL) nationwide due to cGMP deviations involving temperature abuse.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL), 5 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA , NDC 16714-089-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1067-2022·2022-06-15

    Levalbuterol tartrate HFA inhalation aerosol recalled for temperature abuse

    Levalbuterol tartrate HFA inhalation aerosol is being recalled nationwide by McKesson Medical-Surgical due to temperature abuse during storage and distribution. The FDA has classified this as a Class II recall.

    Product
    LEVALBUTEROL TARTRATE HFA INHALATION — LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE)
    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-1076-2022·2022-06-15

    FDA Recalls Proair HFA Albuterol Inhalation Aerosol for Temperature Abuse

    The FDA recalled 56 units of Proair HFA (albuterol sulfate) inhalation aerosol due to temperature abuse during manufacturing. The affected products were distributed nationwide.

    Product
    Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 59310-579-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1079-2022·2022-06-15

    Vecuronium Bromide for Injection Recalled for Manufacturing Temperature Deviation

    McKesson Medical-Surgical is recalling Vecuronium Bromide for Injection (10 mg) manufactured by Teva Pharma USA due to cGMP deviations involving temperature abuse during production. The product was distributed nationwide; no illnesses have been reported.

    Product
    Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only, MFG: Teva Pharma USA, NDC 0703-2914-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (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 (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 (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-1031-2022·2022-06-15

    Baxter Sterile Water for Injection recalled due to manufacturing defects

    McKesson is recalling Baxter Sterile Water for Injection USP (2000 mL) distributed nationwide due to temperature abuse during manufacturing that may compromise sterility.

    Product
    STERILE WATER — STERILE WATER (WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1064-2022·2022-06-15

    MethylPREDNISolone Acetate Injectable Suspension Recalled Due to Temperature Exposure

    McKesson Medical-Surgical is recalling MethylPREDNISolone Acetate Injectable Suspension due to temperature abuse during distribution. The drug was exposed to conditions that could affect its quality and safety.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA, NDC 16714-473-01
    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 (Drugs)·D-1094-2022·2022-06-15

    Labetalol Hydrochloride Tablets Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Labetalol Hydrochloride Tablets 100 mg due to temperature abuse during manufacturing that may affect drug stability. This Class II recall affects units distributed nationwide.

    Product
    Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1074-2022·2022-06-15

    MethylPREDNISolone Acetate Injectable Suspension Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling MethylPREDNISolone Acetate Injectable Suspension due to cGMP deviations involving temperature abuse during manufacturing. Affected vials were distributed nationwide.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5mL (80 mg/mL), 5 mL multi-dose vials, Rx only, MFG: Teva Pharma USA, NDC 0703-0063-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1072-2022·2022-06-15

    Injectable MethyLPREDNISolone Suspension Recalled Due to Temperature Abuse

    MethyLPREDNISolone Acetate Injectable Suspension (400 mg/10 mL) is recalled due to temperature abuse during storage that may have compromised product quality. Approximately 796 vials were distributed nationwide.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL multi-dose vial, Rx only, MFG: Teva Pharma USA, NDC 0703-0045-01
    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 (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 (Drugs)·D-1046-2022·2022-06-15

    Hydroxyzine Pamoate Capsules Recalled Due to Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Hydroxyzine Pamoate Capsules due to cGMP deviations from temperature abuse during manufacturing, which may affect drug stability and potency.

    Product
    HYDROXYZINE PAMOATE — HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE)
    Category
    Drug
    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 (Drugs)·D-1017-2022·2022-06-15

    GlucaGen Glucagon Injection Recalled for Temperature Control Deviations

    GlucaGen (glucagon) injection vials are being recalled due to temperature abuse during manufacturing that may have compromised product stability. The 187 vials were distributed nationwide.

    Product
    GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, Rx only, Manufactured for: Boehringer Mannheim, NDC 0597-0260-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-1005-2022·2022-06-15

    Olanzapine vials recalled nationwide due to temperature exposure

    McKesson Medical-Surgical is recalling Olanzapine 10 mg single-dose vials manufactured by Auromedics due to temperature abuse during distribution. Affected patients should contact their pharmacy or healthcare provider.

    Product
    Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Pharma LLC, NDC# 55150-0308-01
    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-1237-2022·2022-06-15

    Triathlon Tritanium Tibial Components Recalled for Size-Packaging Mismatch

    Howmedica Osteonics is recalling specific lots of Triathlon Tritanium Tibial Components (knee implants) due to a potential mismatch between package labeling and the actual component size contained inside.

    Product
    Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1053-2022·2022-06-15

    Xylocaine Lidocaine Injectable Anesthetic Recalled for Storage Temperature Abuse

    McKesson Medical-Surgical is recalling Xylocaine injectable anesthetic nationwide due to temperature abuse during storage that may compromise medication stability and sterility.

    Product
    XYLOCAINE — XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
    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 (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 (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-1057-2022·2022-06-15

    Promethazine HCl Tablets Recalled Due to Manufacturing Temperature Deviation

    McKesson Medical-Surgical is recalling Promethazine HCl Tablets, 25 mg, due to temperature deviations during manufacturing that did not comply with current good manufacturing practices. The recall affects 16 cartons distributed nationwide.

    Product
    Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6461-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2022·2022-06-15

    Hilal Embolization Microcoils Recalled for Unintended Stainless-Steel Cannula

    Cook Incorporated is recalling Hilal Embolization Microcoils because their loading cartridges may contain an unintended stainless-steel cannula. The recall affects 106,033 units distributed nationwide and internationally.

    Product
    Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1080-2022·2022-06-15

    Revonto dantrolene sodium injection recalled due to temperature abuse during distribution

    McKesson is recalling Revonto (dantrolene sodium injection) due to temperature abuse during storage and distribution affecting 16 cartons distributed nationwide.

    Product
    Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 27505-003-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1007-2022·2022-06-15

    FDA Issues Class II Recall of Sumatriptan Injection Due to Temperature Exposure

    McKesson Medical-Surgical is recalling Sumatriptan Injection, USP, 6mg/0.5mL nationwide due to temperature abuse during distribution that may have affected medication stability and potency.

    Product
    Sumatriptan Injection, USP, 6mg/0.5 mL, packaged in a box of 5 x 0.5 mL single-dose vials, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0173-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1108-2022·2022-06-15

    Tropicamide Ophthalmic Solution recalled for temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling Tropicamide Ophthalmic Solution, 1% USP, due to temperature control deviations during manufacturing. The recall affects 31 bottles distributed nationwide.

    Product
    Tropicamide Ophthalmic Solution, USP 1%, 3 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131435502
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1030-2022·2022-06-15

    Smiths Medical Spinal Tray Recalled Due to Manufacturing Temperature Deviations

    McKesson Medical-Surgical recalls Smiths Medical spinal trays due to manufacturing temperature deviations. Approximately 8 cases were distributed nationwide.

    Product
    Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manufacturer: Smiths Medical ASD, Inc., NJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1056-2022·2022-06-15

    Metronidazole Tablets Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Metronidazole 250 mg tablets manufactured by Major Pharma due to temperature deviations during manufacturing that could affect drug potency. Patients should consult their pharmacist or doctor.

    Product
    Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-1453-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    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 (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 (Devices)·Z-1233-2022·2022-06-15

    Medical imaging software measurement accuracy error in Centricity PACS RA1000

    GE Healthcare's Centricity PACS RA1000 medical imaging software may display inaccurate distance and area measurements on magnified or scaled images, potentially affecting diagnostic accuracy.

    Product
    Centricity PACS RA1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Drugs)·D-1089-2022·2022-06-15

    Injectable Steroid Suspension Recalled Due to Manufacturing Temperature Control Deviation

    Celestone Soluspan injectable suspension is being recalled for manufacturing temperature control deviations that violated good manufacturing practices. McKesson distributed 51 vials nationwide.

    Product
    Celestone Soluspan (betamethasone sodium phosphate and betametasone acetate injectable suspension 6 mg/mL, 30 mg/5mL, multidose vial, Rx only, MFG: Merck Company, NDC 0085-4320-01
    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-1099-2022·2022-06-15

    Drug recall: Thrombin JMI injection kits due to manufacturing temperature deviation

    McKesson Medical-Surgical is recalling 157 kits of Thrombin JMI nationwide due to temperature exposure during manufacturing that may have affected product quality and efficacy.

    Product
    Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-215-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (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-1015-2022·2022-06-15

    Firmagon Injection Recalled Due to Manufacturing Temperature Abuse

    McKesson Medical-Surgical is recalling 25 kits of Firmagon (degarelix for injection) 80 mg nationwide due to temperature abuse during manufacturing. No illnesses have been reported.

    Product
    Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8303-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1096-2022·2022-06-15

    FDA Recalls Depo-Medrol Injectable Due to Temperature Abuse in Manufacturing

    McKesson Medical-Surgical is recalling DEPO-MEDROL (methylprednisolone acetate) injectable suspension nationwide due to temperature abuse during manufacturing that may have affected product quality. No illnesses have been reported.

    Product
    DEPO-MEDROL — DEPO-MEDROL (METHYLPREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1117-2022·2022-06-15

    Cefazolin Sodium injection recalled due to temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling 26 cases of Cefazolin Sodium injection due to manufacturing deviations involving temperature abuse. The product was distributed nationwide.

    Product
    CEFAZOLIN SODIUM — CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1278-2022·2022-06-15

    Sandwich Product Recalled for Potential Insect Filth Contamination

    GRUVIPA S.L. is recalling CB1102052 BOCATA ESPECIAL CASERO'S sandwiches distributed in Florida due to potential insect filth contamination. Consumers should not consume affected products.

    Product
    CB1102052 BOCATA ESPECIAL CASERO'S
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1098-2022·2022-06-15

    Epinephrine injection vials recalled for temperature abuse during distribution

    Epinephrine injection vials are being recalled because they may have been exposed to improper temperatures during distribution, potentially affecting their effectiveness.

    Product
    Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack), Rx only, MFG: Pfizer, NDC 04094-933-01
    Category
    Drug
    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 (Drugs)·D-1061-2022·2022-06-15

    FDA Recalls Methylprednisolone Acetate Injection for Temperature Abuse During Distribution

    McKesson Medical-Surgical is recalling 885 vials of Methylprednisolone Acetate Injectable Suspension USP (40 mg/mL) due to cGMP deviations from temperature abuse. The product was distributed nationwide, but specific lot numbers could not be identified by the distributor.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) single dose vial (NDC 6714-088-01) b) 25-count box (NDC16714-088-25), Rx only, MFG: NorthstarRx/Teva Pharma USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1052-2022·2022-06-15

    Xylocaine injectable anesthetic recalled for temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling Xylocaine injectable vials nationwide due to temperature abuse during manufacturing and distribution. This local anesthetic is used for medical and dental procedures.

    Product
    XYLOCAINE — XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1073-2022·2022-06-15

    Methylprednisolone Acetate Injectable Suspension Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Methylprednisolone Acetate Injectable Suspension nationwide due to temperature abuse during manufacturing that may affect product quality. Healthcare providers should verify receipt.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0051-01) b) 25-count box (NDC 0703-0051-04), Rx only, MFG: Teva Pharma USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2022·2022-06-15

    Emergency relief bed recalled for missing UDI and incorrect weight limit label

    Oakworks Inc is recalling PX200 Emergency Relief Beds due to labeling defects. The product label is missing the UDI number and states an incorrect weight capacity of 500 lbs instead of the actual 400 lb limit.

    Product
    PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
    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-1249-2022·2022-06-15

    Getinge CM320 WUWD Washer Disinfector Installation Verification Issue Recall

    The FDA is recalling 11 Getinge CM320 WUWD washer-disinfectors used for surgical instrument processing. Installation verification was not properly documented or completed, potentially creating risks of electrical shock, burns, and other injuries.

    Product
    Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1118-2022·2022-06-15

    Cefazolin Sodium Injectable Recalled Nationwide for Temperature Abuse

    McKesson Medical-Surgical recalled Cefazolin Sodium injectable (39 cases nationwide) due to temperature abuse during manufacturing that may compromise product sterility.

    Product
    CEFAZOLIN SODIUM — CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Food)·F-1258-2022·2022-06-15

    Trader Joe's Southwestern Chopped Salad Recalled for Undeclared Pistachio Allergen

    Trader Joe's Southwestern Chopped Salad is recalled because it contains an incorrect master pack with undeclared pistachio allergen. Consumers with pistachio allergies should not consume this product.

    Product
    Trader Joe's Southwestern Chopped Salad Contains: Green Cabbage, Romaine, Cotija Cheese, Roasted Pepitas, Tortilla Strips, Green Onion, Cilantro, and a spicy Southwest Avocado Dressing Best if used by: May 26, 2022 Perishable, Keep Refrigerated Product of USA-Mexico Romaine…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-1013-2022·2022-06-15

    FDA Recalls Epinephrine Auto-Injectors Due to Temperature Abuse

    McKesson is recalling 55 packs of epinephrine auto-injectors nationwide due to temperature abuse during manufacturing. This represents a deviation from manufacturing standards.

    Product
    EPINEPHRINE — EPINEPHRINE (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1003-2022·2022-06-15

    Dexmedetomidine vials recalled due to temperature abuse during distribution

    McKesson Medical-Surgical is recalling Dexmedetomidine HCL single-dose vials due to temperature abuse during manufacturing or distribution that may have compromised product quality. No illnesses or injuries have been reported.

    Product
    Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0209-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1235-2022·2022-06-15

    Biliary Electrohydraulic Lithotripter Probe Recalled for Incorrect Product Labeling

    Northgate Technologies is recalling 55 AUTOLITH Touch 1.9F biliary lithotripter probes due to incorrect product labeling. Affected devices were distributed nationwide in Massachusetts.

    Product
    AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1075-2022·2022-06-15

    FDA Recalls Mupirocin Ointment Due to Temperature Control Deviations

    Mupirocin Ointment distributed nationwide is being recalled due to temperature abuse violations during manufacturing. Consumers with affected supplies should contact their pharmacy or healthcare provider for guidance.

    Product
    MUPIROCIN — MUPIROCIN (MUPIROCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1036-2022·2022-06-15

    FDA Recalls MIOSTAT Carbachol Solution Nationwide for Temperature Abuse

    McKesson Medical-Surgical is recalling MIOSTAT (Carbachol Intraocular Solution) nationwide due to temperature abuse during distribution that may affect medication stability.

    Product
    MIOSTAT — MIOSTAT (CARBACHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1032-2022·2022-06-15

    Doxycycline Capsules Recalled for Temperature Control Deviation

    McKesson Medical-Surgical is recalling Doxycycline Capsules, USP, 100 mg due to temperature abuse during manufacturing. The Class II recall affects 3 bottles distributed nationwide across the USA.

    Product
    DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1006-2022·2022-06-15

    Arzol Silver Nitrate Applicator Recalled for Temperature-Related Manufacturing Defects

    McKesson Medical-Surgical is recalling Arzol silver nitrate applicators nationwide due to temperature abuse during manufacturing that may affect product quality.

    Product
    Arzol (Silver Nitrate Applicator), (Silver Nitrate 75%, Potassium Nitrate 25%), 100-count box, Rx only, Manufacturer: Arzol Chemical Co, NDC 12870-0001-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1236-2022·2022-06-15

    1.8mm Truss Wire Component Recalled for Product Upgrade

    New Standard Device Inc is recalling 1.8mm truss wires used in the Metalogix Revolution External Plating System to facilitate introduction of stronger 2.0mm wires.

    Product
    1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1069-2022·2022-06-15

    Medroxyprogesterone acetate injection recalled due to temperature abuse manufacturing deviation

    McKesson Medical-Surgical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) due to temperature abuse during manufacturing. The affected vials were distributed nationwide; patients should contact their healthcare provider.

    Product
    Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials, packaged in a) single dose vial (NDC 0703-6801-01), b) 25-count box single dose vials (NDC 0703-6801-04), Rx only, MFG: Teva Pharma USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0982-2022·2022-06-15

    Ophthalmic Drug Xiidra Recalled for Failed Impurity Specifications

    Novartis is recalling 1,187,092 vials of Xiidra ophthalmic solution nationwide due to failed impurities and degradation specifications in specific lot numbers.

    Product
    XIIDRA — XIIDRA (LIFITEGRAST)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1101-2022·2022-06-15

    Diphenhydramine HCl oral solution recalled for temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling Diphenhydramine HCl oral solution nationwide due to temperature abuse during manufacturing. No illnesses or injuries have been reported.

    Product
    DIPHENHYDRAMINE HYDROCHLORIDE — DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1011-2022·2022-06-15

    FDA Recalls Dihydroergotamine Mesylate Injection for Temperature Abuse

    McKesson Medical-Surgical is recalling Dihydroergotamine Mesylate Injection (NDC 0574-0850-10) due to temperature deviations during manufacturing that may affect product quality. The drug was distributed nationwide.

    Product
    Dihydroergotamine Mesylate, Injection, USP, 1mg/mL, packaged in box of 5 x 1 mL ampules, Rx only, Manufactured for: Perrigo, Minneapolis, MN, NDC 0574-0850-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1271-2022·2022-06-15

    Detox drink recalled for undeclared preservatives and food coloring

    Zydot Ultimate Blend The Original Detox Drink is recalled for undeclared preservatives (potassium sorbate, sodium benzoate) and food coloring R40. The recall involves 1,150 bottles distributed in the USA.

    Product
    Zydot Ultimate Blend The Original Detox Drink Natural Cherry Flavor 16 fl. oz. (473 ml) UPC 754515281439 packaged in plastic bottle with lid
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1107-2022·2022-06-15

    Polymyxin B and Trimethoprim Ophthalmic Solution Recalled Due to Temperature Abuse

    McKesson Medical-Surgical is recalling Polymyxin B and Trimethoprim Ophthalmic Solution nationwide due to temperature deviations during manufacturing. The medication may not work as intended.

    Product
    Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%, 10 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131462810
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1028-2022·2022-06-15

    FDA Recalls Betamethasone Dipropionate Cream for Temperature-Abuse Storage Deviations

    McKesson Medical-Surgical is recalling Betamethasone Dipropionate Cream USP 0.05% due to temperature-abuse cGMP deviations. The FDA Class II recall affects nationwide distribution.

    Product
    Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0055-46
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1001-2022·2022-06-15

    Bupivacaine HCl Injection Recalled for Temperature Control Deviation

    McKesson Medical-Surgical is recalling Bupivacaine HCl Injection (0.50%, multi-dose vials, NDC 55150-0250-50) due to cGMP deviations related to temperature abuse during manufacturing. The product was distributed nationwide.

    Product
    Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1113-2022·2022-06-15

    Tetracaine Hydrochloride Ophthalmic Solution Recalled for Temperature Abuse

    McKesson Medical-Surgical is recalling Tetracaine Hydrochloride Ophthalmic Solution due to cGMP deviations from temperature abuse. The recall affects 43 cartons distributed nationwide.

    Product
    TETRACAINE HYDROCHLORIDE — TETRACAINE HYDROCHLORIDE (TETRACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1090-2022·2022-06-15

    Proventil HFA albuterol inhalers recalled for manufacturing temperature deviation

    Proventil HFA inhalers are being recalled nationwide by McKesson Medical-Surgical due to temperature abuse during manufacturing, a deviation from FDA Good Manufacturing Practice standards.

    Product
    Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalations, Rx only, MFG: Merck Company, NDC 0085-1132-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0999-2022·2022-06-15

    Bupivacaine Injectable Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Bupivacaine HCl Injection vials (NDC 55150-0170-30) distributed nationwide due to temperature abuse during manufacturing that may affect product quality. No illnesses have been reported.

    Product
    Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0170-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1272-2022·2022-06-15

    Zydot Detox Drink Recalled for Missing Ingredient Declarations

    Zydot Unlimited recalls 1,150 bottles of Zydot Ultimate Blend detox drink due to undeclared preservatives and food colorants on the label.

    Product
    Zydot Ultimate Blend The Original Detox Drink Natural Tropical Ice Flavor 16 fl. oz. (473 ml) UPC packaged in plastic bottle with lid
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1077-2022·2022-06-15

    Propofol Injectable Emulsion Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Propofol Injectable Emulsion vials due to cGMP manufacturing deviations involving temperature abuse. No illnesses have been reported.

    Product
    Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) 50 mL vial, in packs of 20 (NDC 00591-2136-51), b) 100 mL vial, in packs of 10 (NDC 00591-2136-68), Rx only, MFG: Teva Pharma USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1047-2022·2022-06-15

    FDA recalls Lidocaine-Prilocaine topical anesthetic cream for temperature abuse

    McKesson Medical-Surgical is recalling Lidocaine and Prilocaine Cream due to cGMP deviations involving temperature abuse during distribution. The recall affects 23 tubes distributed nationwide.

    Product
    LIDOCAINE AND PRILOCAINE — LIDOCAINE AND PRILOCAINE (LIDOCAINE AND PRILOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1043-2022·2022-06-15

    FDA Recalls Prescription Lidocaine Patch Due to Temperature Exposure

    McKesson Medical-Surgical is recalling Lidocaine Patch 5% nationwide due to temperature abuse during distribution that may have compromised product quality. The FDA classified this as a Class II recall.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1078-2022·2022-06-15

    Propofol Injectable Emulsion Recalled for Temperature Abuse During Manufacture

    McKesson Medical-Surgical is recalling Teva Propofol Injectable Emulsion (200 mg/20 mL, 25-vial cartons) nationwide due to temperature abuse during manufacturing that may affect product quality. A total of 564 cartons were distributed.

    Product
    Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials, Rx only, MFG: Teva Pharma USA, NDC 0591-2136-95
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0983-2022·2022-06-15

    Xiidra ophthalmic solution recalled for failed impurity and degradation specifications

    Novartis recalls approximately 1.25 million vials of Xiidra ophthalmic solution nationwide due to failed impurity and degradation specifications. Patients using this product should contact their healthcare provider.

    Product
    Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1083-2022·2022-06-15

    FDA Recalls Transderm Scop Scopolamine Transdermal Patches for Temperature Deviation

    McKesson Medical-Surgical is recalling Transderm Scop (scopolamine) transdermal patches nationwide due to Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. No illnesses have been reported.

    Product
    TRANSDERM SCOP — TRANSDERM SCOP (SCOPOLAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1048-2022·2022-06-15

    FDA Recalls Metronidazole Vaginal Gel Due to Manufacturing Temperature Abuse

    The FDA is recalling Metronidazole Vaginal Gel USP 0.75% due to temperature abuse during manufacturing. The product was distributed nationwide in the United States.

    Product
    Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87
    Category
    Drug
    Distribution
    Distributed nationwide

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