FDA (Drugs) recall action 89646
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.
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.
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.
McKesson Medical-Surgical recalls Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic ointment (120 tubes) nationwide due to temperature storage deviations during manufacturing.
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.
McKesson Medical-Surgical is recalling Sodium Bicarbonate Antacid Tablets nationwide due to temperature abuse during manufacturing. Consumers should consult their healthcare provider about continued use.
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.
McKesson Medical-Surgical is recalling Tetracaine Hydrochloride Ophthalmic Solution due to cGMP deviations from temperature abuse. The recall affects 43 cartons distributed nationwide.
McKesson Medical-Surgical is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) nationwide due to cGMP deviations caused by temperature abuse during manufacturing.
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.
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.
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.
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.
McKesson is recalling 263 vials of MethyLPREDNISolone Acetate Injectable Suspension (200 mg/5 mL) nationwide due to cGMP deviations involving 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.
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.
McKesson Medical-Surgical is recalling Propofol Injectable Emulsion vials due to cGMP manufacturing deviations involving temperature abuse. No illnesses have been reported.
The FDA recalled 56 units of Proair HFA (albuterol sulfate) inhalation aerosol due to temperature abuse during manufacturing. The affected products were distributed nationwide.
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.
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.
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.
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.
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.
McKesson Medical-Surgical is recalling EpiPen 0.3 mg epinephrine auto-injectors due to temperature-related manufacturing deviations during the June-September 2021 distribution period.
McKesson is recalling Baxter Sterile Water for Injection USP (2000 mL) distributed nationwide due to temperature abuse during manufacturing that may compromise sterility.
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.
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.