The Recall Desk

FDA (Drugs) recall action 89646

Mckesson Medical-Surgical Inc. Corporate Office recalled 130 products on 2022-06-15

The FDA (Drugs) publishes a recall like this one as 130 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 130 pages.

Products
130
Announced
2022-06-15
Critical
0
Units
4,238

Why these products were recalled

cGMP deviations: Temperature abuse

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

76–100 of 130

  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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 (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-06-15

    Triamcinolone Acetonide Cream Recalled Due to Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Triamcinolone Acetonide cream nationwide due to cGMP deviations related to temperature abuse during manufacturing. Specific lot numbers of affected product could not be identified.

    Product
    TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states