FDA•MODERATE
BD ChloraPrep Clear Applicators
CareFusion is recalling BD ChloraPrep Clear sterile solution applicators due to a potential lack of sterility from incomplete packaging seals.
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Drugs Recalls
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FDA•MODERATECleviprex Injectable EmulsionChiesi USA is recalling Cleviprex (clevidipine injectable emulsion) 50 mg/100 mL vials due to a lack of assurance of sterility.
FDA•MODERATEBell Pharmaceuticals: Multiple Carbamide Peroxide ProductsBell Pharmaceuticals recalls store-brand carbamide peroxide ear drops for subpotency (low pH, ~0.6% assay).
11 products
FDA•MODERATENystatin Cream USPPadagis is recalling 15 g tubes of Nystatin Cream USP due to subpotent drug results found during stability testing.
FDA•MODERATEPemetrexed for Injection 100mg/VialReliance Life Sciences recalls Pemetrexed for Injection 100mg/Vial over cGMP deviations.
4 products
FDA•MODERATEGasco Industrial: Multiple Isopropyl Alcohol ProductsGasco recalls Isopropyl Alcohol 70% in 16 oz, 32 oz, and 1 gal sizes due to subpotency.
6 products
FDA•LOWFexofenadine Hydrochloride Tablets 180 mgOhm Laboratories is recalling 180 mg Fexofenadine Hydrochloride tablets due to failed impurities and degradation specifications.
FDA•MODERATEMethohexital Sodium 100 mg/10 mLQuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL vials due to failed impurities and degradation specifications.
FDA•MODERATEMedline Remedy Specialized Silicone CreamMedline Remedy Specialized Silicone Cream is recalled due to an out-of-specification result for formaldehyde in the raw material.
FDA•MODERATEMethohexital Sodium for Injection 500 mgAvet Pharmaceuticals is recalling Methohexital Sodium for Injection 500 mg vials due to failed impurities and degradation specifications.
FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets over N-nitroso impurity above safe limit.
3 products
FDA•MODERATEDextroamphetamine/Amphetamine Extended-Release CapsulesLannett is recalling 5 mg Dextroamphetamine/Amphetamine ER capsules due to a labeling mix-up where capsules contain immediate-release pellets.
FDA•MODERATEAsclemed: Multiple Lidocaine Hcl Injection ProductsAsclemed recalls Accucaine kits and Lidocaine HCl injection ampules over sterility concerns.
2 products
FDA•MODERATEGlucagon Emergency KitLupin recalls Glucagon Emergency Kits due to a stability test failure that may impair emergency use.
3 products
FDA•MODERATEGemcitabine InjectionHikma is recalling Gemcitabine Injection due to improper temperature storage.
FDA•MODERATELevothyroxine Sodium Tablets 300 mcgAccord Healthcare is recalling 300 mcg Levothyroxine Sodium Tablets due to subpotency.
FDA•MODERATEprednisoLONE Acetate Ophthalmic Suspension 1%Lupin Pharmaceuticals is recalling three sizes of prednisoLONE Acetate Ophthalmic Suspension 1% due to the presence of a foreign substance.
FDA•MODERATEImuldosa (ustekinumab-srlf) InjectionAccord BioPharma is recalling Imuldosa (ustekinumab-srlf) 130 mg/26 mL injection vials due to a lack of assurance of sterility.
FDA•MODERATEPovi-One 10% Povidone-Iodine Oral AntisepticElevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic due to sub-potency.
FDA•MODERATEPerampanel CIII TabletsSun Pharmaceutical is recalling 6mg Perampanel CIII tablets due to a labeling mix-up where bottles may contain 10mg tablets.
FDA•MODERATELacosamide 100mg TabletsCamber Pharmaceuticals is recalling Lacosamide 100mg tablets due to a potential mix-up with Selexipag 1000 mcg tablets.
2 products
FDA•LOWHydroxyzine Hydrochloride Oral SolutionANI Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution, 10 mg/5 mL, due to the presence of a foreign substance.
FDA•MODERATEDuloxetine Delayed-Release CapsulesDirect Rx is recalling 30 mg Duloxetine Delayed-Release capsules due to N-nitroso-duloxetine impurity levels exceeding FDA limits.
FDA•MODERATEAmgen Corlanor and Sensipar TabletsAmgen recalls Corlanor and Sensipar tablets over foreign substance contamination.
5 products
FDA•MODERATEMethylergonovine Maleate TabletsMajor Pharmaceuticals is recalling 0.2 mg Methylergonovine Maleate Tablets due to subpotency.
FDA•MODERATEFenofibrate Capsules, USP 200 mgAjanta Pharma is recalling Fenofibrate Capsules, USP 200 mg, due to manufacturing process deviations.
FDA•MODERATEKeystone Industries: multiple drugsKeystone recalls 20% benzocaine gels from 7 brands over defective container seals.
7 products
FDA•MODERATEBuprenorphine HCl InjectionPar Health is recalling Buprenorphine HCl Injection due to crystallization identified as Buprenorphine free base.
FDA•MODERATEAripiprazole 30 mg TabletsAjanta Pharma is recalling Aripiprazole 30 mg tablets due to a mix-up with Voriconazole 50 mg tablets.
FDA•MODERATEDabur India: Multiple Made In India ProductsDabur India recalls 14 OTC topical products over CGMP deviations.
14 products
FDA•MODERATEChlorthalidone 25 mg TabletsChlorthalidone 25 mg tablets are being recalled due to failed dissolution specifications.
FDA•LOWFocalin XR 5 mg CapsulesSandoz is recalling Focalin XR 5 mg capsules due to missing or incorrect lot numbers and expiration dates on the product labels.
FDA•MODERATEAlyacen 7/7/7 TabletsGlenmark is recalling Alyacen 7/7/7 tablets due to out-of-specification results for total impurities.
FDA•MODERATEVasopressin 2 Units/2 mL SyringesIntegraDose is recalling Vasopressin 2 Units/2 mL syringes due to subpotency, which may cause the drug to be ineffective.
FDA•MODERATEPAI: Multiple Kerr Insta-char In An ProductsPAI Holdings recalls KERR INSTA-CHAR charcoal products for failing USP/OTC monograph standards.
4 products
FDA•LOWPrimidone 50 mg TabletsAmneal Pharmaceuticals is recalling Primidone 50 mg tablets due to potential cross-contamination with Acemetacin API.
FDA•MODERATEMinocycline Hydrochloride 115 mg TabletsAscend Laboratories is recalling Minocycline Hydrochloride 115 mg tablets due to failed dissolution specifications.
FDA•MODERATEZep Alcohol Sanitizer SprayZep Inc. is recalling 55-gallon containers of Alcohol Sanitizer Spray due to potential microbial contamination.
FDA•MODERATEBudesonide Inhalation SuspensionSun Pharmaceutical is recalling Budesonide Inhalation Suspension (1mg/2mL) due to the presence of foreign black or brown particles.
FDA•MODERATEBreckenridge Pharmaceutical: multiple capsulesBreckenridge recalls Duloxetine capsules over N-nitroso-duloxetine impurity above FDA limit.
2 products
FDA•MODERATECareFusion 213: Multiple Subsidiary Of Beckton ProductsCareFusion recalls BD ChloraPrep and PurPrep applicators over sterility concerns.
10 products
FDA•LOWEpinephrine Injection 1mg/mLFresenius Kabi is recalling Epinephrine Injection 1mg/mL vials due to out-of-specification stability test results.
FDA•MODERATENiacin Extended-release Tablets 1,000 mgLannett is recalling Niacin Extended-release Tablets 1,000 mg due to failed dissolution specifications.
FDA•MODERATEKirkland Signature Ultra Strength AntacidKirkland Signature antacid recalled over metallic particles in chewable tablets.
23 products
FDA•MODERATEXyvona (levorphanol tartrate) 2mg TabletsForte BioPharma recalls Xyvona 2mg tablets over FDA name denial.
2 products
FDA•MODERATEDuloxetine DR Capsules 30 mgAsclemed USA is recalling Duloxetine DR Capsules 30 mg due to the presence of a nitrosamine impurity above acceptable intake limits.
FDA•MODERATELidocaine HCl Injection USPSpectra Medical Devices is recalling Lidocaine HCl Injection USP single-dose ampules due to a lack of assurance of sterility.
FDA•MODERATEAmlodipine and Olmesartan Medoxomil TabletsAscend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, due to failed dissolution specifications.
FDA•LOWLidocaine HCl Injection 2%Eugia US LLC is recalling Lidocaine HCl Injection 2% because the label wrap covers the barcode, making it difficult to scan.
FDA•LOWPred Mild Ophthalmic SuspensionAbbVie is recalling 10 mL bottles of Pred Mild ophthalmic suspension due to failed stability specifications.