FDA (Drugs) recall action 91952
The FDA (Drugs) publishes a recall like this one as 17 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 17 pages.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their 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.
Preferred Pharmaceuticals is recalling Pravastatin Sodium 20 mg tablets nationwide due to manufacturing practice deviations identified during FDA inspection. No illnesses have been reported.
Preferred Pharmaceuticals is recalling Montelukast Sodium Tablets, USP, 10 mg due to current Good Manufacturing Practice deviations discovered during an FDA inspection. The product was distributed nationwide.
Preferred Pharmaceuticals, Inc. is recalling Rosuvastatin Calcium 10 mg tablets nationwide due to cGMP deviations identified during FDA inspection of the manufacturing facility.
Preferred Pharmaceuticals is recalling Simvastatin 40 mg tablets nationwide due to manufacturing practice violations at the production facility. The recall is precautionary.
Preferred Pharmaceuticals is recalling 32 bottles of Tadalafil 20 mg tablets due to manufacturing process deviations identified during FDA inspection. The recalled lots expire January 31, 2024.
Preferred Pharmaceuticals recalls Glimepiride Tablets, 2 mg, 90-count bottles due to manufacturing process deviations discovered during FDA inspection. No illnesses have been reported.
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 80 mg due to manufacturing quality control deviations identified at Accord Healthcare during FDA inspection. Approximately 57 bottles distributed nationwide.
Preferred Pharmaceuticals is recalling Doxazosin Tablets, USP, 4 mg (lot L1522V, expiration 4/30/2025) due to current Good Manufacturing Practice deviations discovered during FDA inspection of the manufacturer, Accord Healthcare. The product was distributed nationwide.
Preferred Pharmaceuticals is recalling Glimepiride Tablets 4 mg due to Current Good Manufacturing Practice (cGMP) deviations identified at the manufacturer, Accord Healthcare. The recall affects 15 bottles distributed nationwide.
Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets (10 mg) distributed nationwide due to manufacturing process deviations identified at Accord Healthcare. Affected lot numbers are A0523D, F14220, and J0622Q.
Preferred Pharmaceuticals is recalling 264 bottles of Rosuvastatin Tablets 5mg nationwide due to manufacturing deviations discovered during FDA inspection. No illnesses have been reported.
Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg nationwide due to manufacturing practice deviations at the manufacturer, Accord Healthcare, Inc., identified during FDA inspection.
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 10 mg due to manufacturing compliance deviations identified at Accord Healthcare. No illnesses or injuries have been reported.
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 20 mg, in three package sizes due to manufacturing process deviations at Accord Healthcare. The affected tablets were distributed nationwide.
Preferred Pharmaceuticals is recalling Clopidogrel Tablets 75 mg nationwide due to manufacturing quality deviations found at manufacturer Accord Healthcare. The recall affects specific lot codes expiring October 2023.
Preferred Pharmaceuticals recalls Doxazosin Tablets USP 2 mg (Lot H3122K, expires 5/31/2024) due to current Good Manufacturing Practice deviations identified at the manufacturing facility.
Preferred Pharmaceuticals is recalling specific lots of Finasteride Tablets, 5 mg due to manufacturing process deviations discovered during FDA inspection of manufacturer Accord Healthcare. No illnesses or injuries have been reported.