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 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.
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.
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 Glucagon Emergency Kits nationwide due to temperature abuse during manufacturing, which may affect drug efficacy. Patients should contact their healthcare provider.
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 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 Albuterol Sulfate Inhalation Aerosol HFA due to temperature exposure during manufacturing that caused deviations from manufacturing practice standards. The affected product was distributed nationwide.
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 Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during distribution that may affect product quality and efficacy. Affected patches were distributed nationwide.
McKesson Medical-Surgical is recalling ClomiPHENE Citrate Tablets 50 mg due to temperature abuse during distribution. The medication was distributed nationwide; patients should contact their healthcare provider for guidance.
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.
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 21 bottles of Apraclonidine 0.5% ophthalmic solution due to cGMP deviations involving temperature abuse during manufacturing. The temperature exposure may reduce drug efficacy.
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.
McKesson Medical-Surgical is recalling Ketoconazole Cream 2% (60-gram tubes) distributed nationwide due to cGMP deviations involving temperature abuse during manufacturing.
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 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 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 Propofol Injectable Emulsion vials due to cGMP manufacturing deviations involving temperature abuse. No illnesses have been reported.
McKesson Medical-Surgical is recalling Glucagen (glucagon) 1 mg injection vials nationwide due to temperature abuse during manufacturing and distribution, a cGMP deviation.
McKesson Medical-Surgical is recalling albuterol sulfate inhalation solution 0.021% (0.63 mg/3mL vials) distributed nationwide. The FDA Class II recall is due to cGMP deviations involving temperature abuse.
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 15 boxes of Firmagon degarelix injection due to temperature abuse during distribution. The temperature exposure may compromise the pharmaceutical's stability and safety.
McKesson Medical-Surgical is recalling Bupivacaine HCl Injection due to cGMP deviations caused by temperature abuse during manufacturing. The recall affects 32 cartons of 25-vial packages distributed nationwide.
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.