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.
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 Levofloxacin 500 mg tablets nationwide due to temperature abuse during manufacturing that violated pharmaceutical quality standards.
McKesson Medical-Surgical is recalling Topex benzocaine 20% topical anesthetic gel due to cGMP deviations involving temperature abuse during manufacturing. The recall affects 24 bottles distributed nationwide.
McKesson Medical-Surgical is recalling Metoprolol 50 mg tablets nationwide due to temperature abuse during manufacturing that may compromise medication stability. Patients should contact their pharmacist or physician.
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 21 bottles of Apraclonidine 0.5% ophthalmic solution due to cGMP deviations involving temperature abuse during manufacturing. The temperature exposure may reduce drug efficacy.
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.
McKesson Medical-Surgical is recalling 13 bottles of Isopto Atropine 1% ophthalmic solution due to temperature-abuse violations of manufacturing standards that may have affected product sterility.
McKesson Medical-Surgical is recalling Olanzapine Orally Disintegrating Tablets 10 mg nationwide due to temperature abuse during manufacturing that may have affected product stability. Patients should consult their healthcare provider about their medication.
McKesson is recalling Ciprofloxacin Ophthalmic Solution 0.3% nationwide due to temperature deviations during manufacturing. The FDA classifies this as a Class II recall.
McKesson Medical-Surgical is recalling Ciprofloxacin Hydrochloride 0.3% ophthalmic solution nationwide due to temperature abuse, a cGMP violation that may compromise product integrity.
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 15 boxes of Firmagon degarelix injection due to temperature abuse during distribution. The temperature exposure may compromise the pharmaceutical's stability and safety.
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 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 Lidocaine Patch 5% due to temperature abuse during storage and distribution. Affected patches may not function properly. Patients should consult their healthcare provider.
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 is recalling Miochol E intraocular solution due to temperature abuse during distribution. The product should not be used if received between June 1 and September 30, 2021.
McKesson Medical-Surgical is recalling BSS sterile irrigating solution nationwide due to cGMP deviations involving temperature abuse during manufacturing. The recall affects prescription-only ophthalmic solutions.
McKesson Medical-Surgical is recalling Albuterol Sulfate Inhalation Solution nationwide due to temperature deviations during manufacturing that may have compromised product quality. No illnesses have been reported.
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 temperature-abuse cGMP deviations affecting 363 vials distributed nationwide.
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 MIOSTAT (Carbachol Intraocular Solution) nationwide due to temperature abuse during distribution that may affect medication stability.
Bupivacaine HCl Injection multi-dose vials are being recalled due to temperature abuse during manufacturing. The product was distributed nationwide. Patients should consult their healthcare provider for alternative treatments.