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.
Intralipid intravenous fat emulsion is being recalled due to cGMP manufacturing deviations involving temperature abuse. The product was distributed nationwide.
McKesson Medical-Surgical recalled Cefazolin Sodium injectable (39 cases nationwide) due to temperature abuse during manufacturing that may compromise product sterility.
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 is recalling 55 packs of epinephrine auto-injectors nationwide due to temperature abuse during manufacturing. This represents a deviation from manufacturing standards.
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.