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 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 Ipratropium Bromide Inhalation Solution nationwide due to current good manufacturing practice (cGMP) deviations involving temperature control. The FDA has classified this as a Class II recall.
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.
McKesson Medical-Surgical is recalling Hydroxyzine Pamoate Capsules due to cGMP deviations from temperature abuse during manufacturing, which may affect drug stability and potency.
McKesson Medical-Surgical is recalling Azithromycin for Injection 500 mg vials nationwide due to temperature control deviations identified during manufacturing.
Revonto (dantrolene sodium) injection is being recalled due to manufacturing deviations involving temperature abuse. Approximately 49 cartons were distributed nationwide; healthcare providers should contact their supplier for guidance.
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 MethylPREDNISolone Acetate Injectable Suspension due to temperature abuse during distribution. The drug was exposed to conditions that could affect its quality and safety.
McKesson is recalling Ciprofloxacin Ophthalmic Solution 0.3% nationwide due to temperature deviations during manufacturing. The FDA classifies this as a Class II recall.
Celestone Soluspan injectable suspension is being recalled for manufacturing temperature control deviations that violated good manufacturing practices. McKesson distributed 51 vials nationwide.
McKesson Medical-Surgical is recalling Sumatriptan Succinate 100 mg tablets due to temperature abuse during manufacturing that may affect quality. Consumers should consult their physician or pharmacist about whether they have an affected product.
McKesson Medical-Surgical is recalling MethylPREDNISolone Acetate Injectable Suspension due to cGMP deviations involving temperature abuse during manufacturing. Affected vials were distributed nationwide.
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.
McKesson Medical-Surgical is recalling 26 cases of Cefazolin Sodium injection due to manufacturing deviations involving temperature abuse. The product was distributed nationwide.
McKesson Medical-Surgical is recalling Ibuprofen 400 mg prescription tablets nationwide due to temperature abuse during manufacturing. The manufacturing deviation may affect drug stability and efficacy.
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.
Prednisolone Acetate ophthalmic suspension is being recalled nationwide due to temperature deviations during distribution. McKesson Medical-Surgical has notified affected customers.
McKesson Medical-Surgical is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) nationwide due to cGMP deviations caused by temperature abuse during manufacturing.
Mckesson Medical-Surgical is recalling MethyLPREDNISolone Acetate Injectable Suspension due to temperature-abuse cGMP deviations affecting 363 vials distributed nationwide.
McKesson Medical-Surgical is recalling DIPRIVAN (Propofol) injectables nationwide due to temperature abuse during distribution that may have affected product stability. The recall involves 46 cartons.
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 is recalling RECOTHROM (Thrombin Topical Recombinant) because products were subjected to temperature abuse during storage or distribution, causing a cGMP (manufacturing practice) deviation.
McKesson is recalling Revonto (dantrolene sodium injection) due to temperature abuse during storage and distribution affecting 16 cartons distributed nationwide.
McKesson is recalling 55 packs of epinephrine auto-injectors nationwide due to temperature abuse during manufacturing. This represents a deviation from manufacturing standards.
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.