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 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 Doxycycline Capsules, USP, 100 mg due to temperature abuse during manufacturing. The Class II recall affects 3 bottles distributed nationwide across the USA.
McKesson is recalling Bone Marrow Biopsy Trays with Lidocaine due to cGMP deviations from temperature abuse. Product was distributed nationwide.
McKesson is recalling Loperamide Hydrochloride 2 mg capsules nationwide due to cGMP deviations involving temperature abuse during manufacturing that may affect medication stability.
McKesson Medical-Surgical is recalling Tropicamide Ophthalmic Solution, 1% USP, due to temperature control deviations during manufacturing. The recall affects 31 bottles distributed nationwide.
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.
McKesson Medical-Surgical is recalling Paracentesis/Thoracentesis Trays that were subjected to temperature abuse during distribution, which may compromise the sterility and efficacy of the included Lidocaine Hydrochloride. No illnesses have been reported.
McKesson Medical-Surgical is recalling Xylocaine injectable anesthetic nationwide due to temperature abuse during storage that may compromise medication stability and sterility.
Geodon for injection (ziprasidone hydrochloride) 20 mg/mL vials are being recalled nationwide due to cGMP deviations involving temperature abuse. The FDA classified this as a Class II recall.
Epinephrine auto-injectors distributed nationwide are being recalled due to temperature abuse during manufacturing. Temperature exposure may degrade the medication and reduce its emergency effectiveness.
McKesson Medical-Surgical is recalling EpiPen Jr epinephrine auto-injectors nationwide due to temperature exposure during manufacturing that may degrade medication potency.
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.
McKesson Medical-Surgical is recalling MethyLPREDNISolone Acetate Injectable Suspension due to temperature abuse during storage that may compromise sterility and efficacy. The recall affects 65 vials 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 Hydrocortisone Ointment USP 2.5% nationwide due to temperature abuse during distribution that violated manufacturing standards.
McKesson Medical-Surgical is recalling Nitrostat (nitroglycerin sublingual tablets) 0.4 mg due to manufacturing deviations involving temperature abuse that may affect product quality. The affected product was distributed nationwide.
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.
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.
McKesson Medical-Surgical is recalling Arzol silver nitrate applicators nationwide due to temperature abuse during manufacturing that may affect product quality.
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.
McKesson is recalling Diprivan (Propofol) injection due to manufacturing temperature deviations that may affect drug stability. The FDA Class II recall involves 122 cartons distributed nationwide to medical settings.
McKesson Medical-Surgical is recalling Bupivacaine Hydrochloride Injection due to temperature abuse during storage that may have compromised product sterility. The recall affects 224 cartons distributed nationwide.
McKesson Medical-Surgical is recalling MIOSTAT (Carbachol Intraocular Solution) nationwide due to temperature abuse during distribution that may affect medication stability.
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.
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.