FDA (Drugs) recall action 91657
The FDA (Drugs) publishes a recall like this one as 67 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 67 pages.
CGMP Deviations: recalling drug products following an FDA inspection.
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.
Accord Healthcare is recalling Glycopyrrolate Injection due to manufacturing process deviations found during FDA inspection. The recall involves 5,273 vials distributed across the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling Finasteride 5 mg tablets due to manufacturing process deviations discovered during FDA inspection. Over 2.7 million bottles distributed in the US, Puerto Rico, and Canada are affected.
Accord Healthcare recalls 181,848 bottles of Ropinirole 0.5 mg tablets distributed in the U.S., Canada, and Puerto Rico due to manufacturing practice deviations identified during an FDA inspection.
Accord Healthcare is recalling Doxazosin 2 mg tablets distributed across the United States, Puerto Rico, and Canada due to manufacturing practice deviations identified during an FDA inspection.
Accord Healthcare recalls Atorvastatin Calcium 80 mg tablets due to manufacturing process deviations identified during FDA inspection. 72,376 bottles were distributed in the US, Puerto Rico, and Canada.
Accord Healthcare is recalling approximately 25,812 bottles of Buspirone Hydrochloride 30mg tablets due to manufacturing practice deviations discovered during an FDA inspection.
Accord Healthcare recalls approximately 665,469 bottles of Montelukast Sodium 10 mg tablets due to manufacturing process deviations discovered during FDA inspection.
Accord Healthcare is recalling 147,736 bottles of Atorvastatin Calcium 40 mg tablets due to manufacturing practice deviations discovered during an FDA inspection.
Accord Healthcare is recalling Atorvastatin Calcium 10 mg tablets distributed in the United States, Puerto Rico, and Canada following FDA inspection findings of manufacturing deviations.
Accord Healthcare recalls Glycopyrrolate injection due to manufacturing practice deviations found during FDA inspection. The recall affects 3,164 vials distributed in the US, Puerto Rico, and Canada.
Accord Healthcare is recalling Tadalafil 10 mg tablets in the United States, Puerto Rico, and Canada due to manufacturing quality control deviations discovered during an FDA inspection.
Accord Healthcare recalls 539,004 bottles of Aripiprazole 10 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing process deviations found during an FDA inspection.
Accord Healthcare is recalling Aripiprazole 15 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during an FDA inspection.
Accord Healthcare is recalling 1,190,484 bottles of Simvastatin 40 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations identified during an FDA inspection.
Accord Healthcare recalled 1.4 million bottles of Finasteride 1 mg tablets due to manufacturing quality deviations discovered during FDA inspection. No illnesses have been reported.
Accord Healthcare is recalling Tadalafil 2.5 mg tablets following discovery of manufacturing deviations during an FDA inspection. Approximately 36,773 bottles were distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling Pravastatin Sodium Tablets USP 40 mg due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 120 bottles distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling 44,068 bottles of Doxazosin 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations found during an FDA inspection.
Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing deviations found during FDA inspection. No illnesses or injuries have been reported.
Accord Healthcare's Ropinirole 3mg tablets are being recalled due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 14,928 bottles distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling Buspirone Hydrochloride 7.5 mg tablets (23,784 bottles) distributed in the US, Puerto Rico, and Canada due to manufacturing practice deviations identified during FDA inspection.
Accord Healthcare is recalling Succinylcholine Chloride Injection due to manufacturing practice deviations discovered during FDA inspection. The recall affects 48,089 cartons distributed to the U.S., Puerto Rico, and Canada.
Accord Healthcare is recalling Simvastatin 20 mg tablets due to manufacturing practice deviations discovered during an FDA inspection. The recall affects 1,394,208 bottles distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare recalls Daptomycin for Injection in the US, Puerto Rico, and Canada affecting 65,233 vials due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection.
Accord Healthcare is recalling Simvastatin 80 mg tablets due to manufacturing practice deviations discovered during an FDA inspection. Approximately 205,631 bottles are affected across the US, Puerto Rico, and Canada.