Category
FDA recalls of prescription and over-the-counter drugs.
FDA drug recalls cover prescription medicines, over-the-counter products, biologic and gene therapies, and active pharmaceutical ingredients (the raw drug substances that manufacturers compound into finished products). Recall classifications follow the same Class I / II / III system as food, and most published recalls are Class II — the product is unlikely to cause permanent harm but doesn't meet specification.
The most common reasons for a drug recall are out-of-specification potency or dissolution (the active ingredient is present in too high or too low a dose), microbial contamination, particulate matter in injectables, mix-ups during packaging where bottles end up with the wrong tablets, and nitrosamine impurities in certain drug classes. Many drug recalls are at the lot level — the manufacturer's whole product line is still safe to use, but specific production lots are pulled.
If a recall affects your medication: don't stop taking it on your own. Call your prescriber or pharmacist before doing anything. Stopping a prescribed drug abruptly can be more dangerous than the issue prompting the recall. Most drug-recall remedies route through the dispensing pharmacy, who'll either swap your supply for an unaffected lot or coordinate a refund with the manufacturer.
Revonto (dantrolene sodium) injection is being recalled due to manufacturing deviations involving temperature abuse. Approximately 49 cartons were distributed nationwide; healthcare providers should contact their supplier for guidance.
Proventil HFA inhalers are being recalled nationwide by McKesson Medical-Surgical due to temperature abuse during manufacturing, a deviation from FDA Good Manufacturing Practice standards.
McKesson Medical-Surgical has recalled Ipratropium Bromide and Albuterol Sulfate inhalation solution due to temperature abuse during storage that resulted in cGMP deviations. The nationwide recall affects 56 pouches; no illnesses or injuries have been reported.
Teva Pharmaceuticals USA Inc is recalling Alprostadil Injection USP due to out-of-specification results for impurities identified during routine stability testing. This FDA Class III recall affects 3,109 cartons distributed nationwide.
McKesson Medical-Surgical is recalling 29 boxes of Aprepitant 40 mg capsules nationwide due to temperature abuse during manufacturing that violated current Good Manufacturing Practice standards.
McKesson Medical-Surgical is recalling Doxycycline Capsules, USP, 100 mg due to temperature abuse during manufacturing. The Class II recall affects 3 bottles distributed nationwide across the USA.
McKesson Medical-Surgical is recalling Tetracaine Hydrochloride Ophthalmic Solution due to cGMP deviations from temperature abuse. The recall affects 43 cartons distributed nationwide.
McKesson Medical-Surgical is recalling Bupivacaine HCl Injection (0.50%, multi-dose vials, NDC 55150-0250-50) due to cGMP deviations related to temperature abuse during manufacturing. The product was distributed nationwide.
McKesson Medical-Surgical is recalling MIOSTAT (Carbachol Intraocular Solution) nationwide due to temperature abuse during distribution that may affect medication stability.
McKesson Medical-Surgical is recalling TOBRADEX ophthalmic ointment nationwide due to cGMP deviations involving temperature abuse. Product distributed between June 1 and September 30, 2021 may be affected.
McKesson Medical-Surgical is recalling Naltrexone Hydrochloride 50 mg tablets distributed nationwide due to cGMP deviations related to temperature abuse during manufacturing.
McKesson Medical-Surgical is recalling Betamethasone Dipropionate Cream USP 0.05% due to temperature-abuse cGMP deviations. The FDA Class II recall affects nationwide distribution.
McKesson Medical-Surgical is recalling Polymyxin B and Trimethoprim Ophthalmic Solution nationwide due to temperature deviations during manufacturing. The medication may not work as intended.
Teva Pharmaceuticals is recalling Anagrelide Capsules USP 0.5 mg nationwide due to failed dissolution specifications discovered during stability testing. The recall involves lot GD01090 (expired May 2022).
Strides Pharma Inc. is recalling Losartan Potassium 50 mg tablets distributed nationwide due to AZIDO impurity levels exceeding acceptable FDA manufacturing standards.
Busse Hospital Disposables is recalling Nerve Block Tray kits containing swab drug products due to uncertainty regarding adequate validation of test methods during manufacturing. The recall involves 250 units distributed nationwide.
Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The compounded injectable drug may not meet sterile product standards.
Nephron Sterile Compounding Center LLC is recalling succinylcholine chloride injection due to lack of sterility assurance. The recall involves 181,560 pre-filled syringes distributed nationwide.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about manufacturing test method validation.
AMBI Skincare Fade Cream is being recalled nationwide due to cGMP violations. The product was stored outside its labeled temperature requirements during manufacturing.
Nephron Sterile Compounding Center is recalling 134,415 pre-filled syringes of Epinephrine Injection due to lack of assurance of sterility. Affected lots were distributed nationwide; patients and providers should contact their healthcare provider.
Nephron Sterile Compounding Center LLC is recalling 30,290 syringes of Ketamine Hydrochloride Injection due to lack of assurance of sterility. The injectable drug was distributed nationwide.
Busse Hospital Disposables is recalling I.V. Start Kit (Catalog 8172) due to inadequate validation of manufacturing processes for the included swab drug products. The recall affects 4,218 units distributed nationwide.
Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Patients should contact their healthcare provider to verify if they are affected.
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. Approximately 57,810 syringes were distributed nationwide.
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