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 263 vials of MethyLPREDNISolone Acetate Injectable Suspension (200 mg/5 mL) nationwide due to cGMP deviations involving temperature abuse.
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 Ciprofloxacin Hydrochloride 0.3% ophthalmic solution nationwide due to temperature abuse, a cGMP violation that may compromise product integrity.
MethyLPREDNISolone Acetate Injectable Suspension (400 mg/10 mL) is recalled due to temperature abuse during storage that may have compromised product quality. Approximately 796 vials were distributed nationwide.
Intralipid intravenous fat emulsion is being recalled due to cGMP manufacturing deviations involving temperature abuse. The product was distributed nationwide.