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 Doxycycline Capsules, USP, 100 mg due to temperature abuse during manufacturing. The Class II recall affects 3 bottles distributed nationwide across the USA.
McKesson Medical-Surgical is recalling Amoxicillin 500mg capsules distributed nationwide due to temperature abuse during manufacturing that may compromise product potency and effectiveness.
Mckesson Medical-Surgical is recalling Meclizine Hydrochloride 25mg tablets nationwide due to manufacturing deviations involving improper temperature control. The FDA classified this as a Class II recall.
McKesson Medical-Surgical is recalling Arzol silver nitrate applicators nationwide due to temperature abuse during manufacturing that may affect product quality.
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 Medical-Surgical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) due to temperature abuse during manufacturing. The affected vials were distributed nationwide; patients should contact their healthcare provider.
McKesson is recalling doxycycline hyclate 100 mg tablets nationwide due to temperature abuse during manufacturing that fails to meet good manufacturing practice standards.
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.
FDA is recalling Kinevac (Sincalide for Injection), a prescription injectable drug distributed nationwide, due to cGMP deviations involving temperature abuse during manufacturing.
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 recalls 780 vials of medroxyprogesterone acetate injectable suspension nationwide due to temperature exposure during distribution that may affect medication stability.
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 Albuterol Sulfate Inhalation Solution due to manufacturing deviations involving temperature abuse. The medication was distributed nationwide.
McKesson Medical-Surgical is recalling Diphenhydramine HCl oral solution nationwide due to temperature abuse during manufacturing. No illnesses or injuries have been reported.
McKesson is recalling Ondansetron Hydrochloride 8 mg tablets distributed nationwide due to temperature abuse during storage that may affect medication stability. Patients should contact their pharmacy or doctor.
McKesson Medical-Surgical is recalling Intralipid intravenous fat emulsion distributed nationwide due to cGMP deviations involving temperature abuse that could compromise product safety.
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 is recalling Bone Marrow Biopsy Trays with Lidocaine due to cGMP deviations from temperature abuse. Product was distributed nationwide.
Mckesson Medical-Surgical is recalling Ofloxacin Otic Solution nationwide due to exposure to improper storage temperatures that violated manufacturing standards.
FDA recalls 63 bottles of Clonidine Hydrochloride Tablets (0.1 mg, NDC 00228-2127-10) distributed nationwide due to temperature abuse causing cGMP deviations during manufacturing.
McKesson Medical-Surgical Inc. is recalling injectable Pantoprazole Sodium for Injection due to manufacturing deviations involving temperature abuse. The nationwide recall affects a 10-vial carton; no illnesses have been reported.
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 Betamethasone Dipropionate Cream USP 0.05% due to temperature-abuse cGMP deviations. The FDA Class II recall affects nationwide distribution.
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 Verapamil HCL injection ampules (NDC 04094-011-01) distributed nationwide due to temperature abuse during manufacturing.