FDA (Drugs) recall action 89450
The FDA (Drugs) publishes a recall like this one as 42 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 42 pages.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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.
SPIRIVA (tiotropium bromide) inhalation powder batch 104440 is being recalled nationwide due to exposure to temperatures outside the product's labeled storage conditions during manufacturing.
A prescription lansoprazole suspension has been recalled because batches were exposed to temperatures outside the manufacturer's labeled storage range. This manufacturing quality issue affects Batch 21025A nationwide.
Cardinal Healthcare is recalling Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg, 18-tablet cartons) nationwide because products were exposed to temperatures outside the labeled storage conditions. Batch P125514 is affected.
Triamterene and Hydrochlorothiazide Capsules (37.5 mg/25 mg) are being recalled nationwide due to temperature exposure during manufacturing that fell outside labeled storage conditions. Affected batches are 21000279A and 21000280A.
Cardinal Healthcare is recalling Estradiol 0.5mg tablets (Batch 100023687) nationwide due to exposure to temperatures outside labeled storage specifications. Temperature exposure may affect medication stability.
Cardinal Healthcare is recalling Doxycycline 100 mg Capsules nationwide due to exposure to temperatures outside labeled storage conditions. No illnesses have been reported.
Cardinal Healthcare is recalling Fluticasone Propionate Nasal Spray (50MCG per spray) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Nationwide distribution affected.
Cardinal Healthcare is recalling Lisinopril and Hydrochlorothiazide Tablets (10mg/12.5mg) manufactured by Lupin Limited because products were exposed to temperatures outside the labeled storage conditions. Affected batches are Q101699 and Q101981 distributed nationwide.
Cardinal Healthcare is recalling Hydralazine Hydrochloride tablets nationwide because products were exposed to temperatures outside labeled storage conditions due to manufacturing practice deviations.
Lillow oral contraceptive tablets (batch A5921) have been recalled nationwide by Cardinal Healthcare due to exposure to temperatures outside labeled storage conditions.
Colgate Total SF Toothpaste (Batch 1293US561C, 4.8 oz, Clean Mint) distributed nationwide is being recalled due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions.
Cardinal Healthcare is recalling Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide. Batch 2447J211 was exposed to temperatures outside labeled storage conditions, which could compromise medication effectiveness.
Propranolol Hydrochloride tablets have been recalled nationwide. Products were exposed to temperatures outside labeled storage conditions during manufacturing, potentially affecting drug stability.
CARDINAL HEALTHCARE is recalling Amoxicillin for Oral Suspension nationwide due to CGMP deviations. Products were exposed to temperatures outside their labeled storage conditions.
Cardinal Healthcare is recalling Dicyclomine Hydrochloride 20 mg tablets due to temperature exposure outside labeled storage conditions. No illnesses have been reported.
Cardinal Healthcare is recalling Chlorthalidone Tablets, 25mg (Batch 2107329UM) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.
Jardiance 25 mg tablets distributed nationwide were recalled due to CGMP deviations where products were exposed to temperatures outside the labeled storage conditions. The recall affects batch D41919.