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.
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.
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 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.
Celestone Soluspan injectable suspension is being recalled for manufacturing temperature control deviations that violated good manufacturing practices. McKesson distributed 51 vials nationwide.
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 Bupivacaine HCl Injection due to cGMP deviations caused by temperature abuse during manufacturing. The recall affects 32 cartons of 25-vial packages distributed nationwide.
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 is recalling TOBRADEX ophthalmic ointment nationwide due to cGMP deviations involving temperature abuse. Product distributed between June 1 and September 30, 2021 may be affected.
McKesson Medical-Surgical is recalling 25 kits of Firmagon (degarelix for injection) 80 mg nationwide due to temperature abuse during manufacturing. No illnesses have been reported.
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 26 cases of Cefazolin Sodium injection due to manufacturing deviations involving temperature abuse. The product was distributed nationwide.
Epinephrine injection vials are being recalled because they may have been exposed to improper temperatures during distribution, potentially affecting their effectiveness.
Revonto (dantrolene sodium) injection is being recalled due to manufacturing deviations involving temperature abuse. Approximately 49 cartons were distributed nationwide; healthcare providers should contact their supplier for guidance.
McKesson Medical-Surgical is recalling 885 vials of Methylprednisolone Acetate Injectable Suspension USP (40 mg/mL) due to cGMP deviations from temperature abuse. The product was distributed nationwide, but specific lot numbers could not be identified by the distributor.
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 Azithromycin for Injection 500 mg vials nationwide due to temperature control deviations identified during manufacturing.
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 Naltrexone Hydrochloride 50 mg tablets distributed nationwide due to cGMP deviations related to temperature abuse during manufacturing.
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 29 boxes of Aprepitant 40 mg capsules nationwide due to temperature abuse during manufacturing that violated current Good Manufacturing Practice standards.
McKesson Medical-Surgical is recalling DIPRIVAN (Propofol) injectables nationwide due to temperature abuse during distribution that may have affected product stability. The recall involves 46 cartons.
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 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 Depo-Medrol (methylprednisolone acetate) 80mg/mL injectable suspension due to manufacturing temperature control deviations. The recall affects 177 cartons distributed nationwide.
McKesson Medical-Surgical is recalling Albuterol Sulfate Inhalation Aerosol nationwide due to temperature abuse during distribution that may affect drug stability.