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.
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 is recalling Teva Propofol Injectable Emulsion (200 mg/20 mL, 25-vial cartons) nationwide due to temperature abuse during manufacturing that may affect product quality. A total of 564 cartons were distributed.
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 Transderm Scop (scopolamine) transdermal patches nationwide due to Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. No illnesses have been reported.
McKesson Medical-Surgical has recalled Ipratropium Bromide and Albuterol Sulfate inhalation solution due to temperature abuse during storage that resulted in cGMP deviations. The nationwide recall affects 56 pouches; no illnesses or injuries have been reported.
McKesson Medical-Surgical is recalling Methylprednisolone Acetate Injectable Suspension nationwide due to temperature control violations in manufacturing. The affected product was distributed to healthcare providers across the United States.
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 Medical-Surgical is recalling 157 kits of Thrombin JMI nationwide due to temperature exposure during manufacturing that may have affected product quality and efficacy.
McKesson Medical-Surgical recalled Cefazolin Sodium injectable (39 cases nationwide) due to temperature abuse during manufacturing that may compromise product sterility.
McKesson is recalling 9 vials of Duraclon (clonidine HCl) injection nationwide due to temperature deviations that violated current Good Manufacturing Practice (cGMP) standards.
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 Dexmedetomidine HCL single-dose vials due to temperature abuse during manufacturing or distribution that may have compromised product quality. No illnesses or injuries have been reported.
Epinephrine injection vials are being recalled because they may have been exposed to improper temperatures during distribution, potentially affecting their effectiveness.
McKesson Medical-Surgical is recalling Metronidazole 250 mg tablets manufactured by Major Pharma due to temperature deviations during manufacturing that could affect drug potency. Patients should consult their pharmacist or doctor.
Proventil HFA inhalers are being recalled nationwide by McKesson Medical-Surgical due to temperature abuse during manufacturing, a deviation from FDA Good Manufacturing Practice standards.
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 Labetalol Hydrochloride Tablets 100 mg due to temperature abuse during manufacturing that may affect drug stability. This Class II recall affects units distributed nationwide.
McKesson Medical-Surgical is recalling Triamcinolone Acetonide cream nationwide due to cGMP deviations related to temperature abuse during manufacturing. Specific lot numbers of affected product could not be identified.
McKesson Medical-Surgical is recalling Ampicillin for Injection nationwide due to cGMP deviations involving temperature abuse during manufacturing that may have compromised drug quality.
McKesson Medical-Surgical is recalling Verapamil HCL injection ampules (NDC 04094-011-01) distributed nationwide due to temperature abuse during manufacturing.
McKesson Medical-Surgical is recalling Betadine 5% Sterile Ophthalmic Prep Solution nationwide due to manufacturing deviations involving temperature abuse during production.
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.
The FDA recalled 56 units of Proair HFA (albuterol sulfate) inhalation aerosol due to temperature abuse during manufacturing. The affected products were distributed nationwide.
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 Levofloxacin 500 mg tablets nationwide due to temperature abuse during manufacturing that violated pharmaceutical quality standards.