FDA•MODERATE
CareFusion 213: Multiple Subsidiary Of Beckton Products
CareFusion recalls BD ChloraPrep and PurPrep applicators over sterility concerns.
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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•MODERATEToxiBan Charcoal-Kaolin SuspensionLloyd is recalling ToxiBan Charcoal-Kaolin Suspension for domestic animals due to microbial levels exceeding specification limits.
FDA•MODERATEFentanyl Citrate Sterile CADD for InjectionIntegraDose is recalling Fentanyl Citrate Sterile CADD for Injection (NDC 71139-6030-1) due to the product being subpotent.
FDA•MODERATENephronex Vitamin B-Complex, Vitamin C & Folic Acid LiquidSafecor Health is recalling Nephronex dietary supplement liquid due to the presence of foreign black particles.
FDA•MODERATEEstradiol Gel 0.1%ANI Pharmaceuticals is recalling Estradiol Gel 0.1% due to defective packets that may be empty or partially full.
FDA•MODERATECimzia Prefilled SyringesUCB is recalling Cimzia prefilled syringes and starter kits due to a lack of assurance of sterility.
FDA•MODERATEErythromycin Tablets 250 mgZydus recalls Erythromycin 250 mg tablets over impurity above acceptable limit.
2 products
FDA•MODERATEGas-X Simethicone 125 mg SoftGelsHaleon is recalling Gas-X Simethicone 125 mg SoftGels (120 count), UPC 3 00674 35041 9, due to incomplete inactive ingredient labeling.
FDA•MODERATELiraglutide InjectionLupin is recalling Liraglutide Injection (NDC 70748-346-02 and 70748-346-03) due to white thread-like particulate matter in the cartridge.
FDA•MODERATEAtomoxetine HCl CapsulesSafecor Health is recalling Atomoxetine HCl capsules due to a labeling mix-up that may result in patients receiving an incorrect dosage.
FDA•MODERATEOphthavet Ophthalmic SolutionDechra is recalling Ophthavet Ophthalmic Solution for dogs and cats due to a lack of sterility assurance.
FDA•MODERATEMetoprolol Succinate Extended-Release Tablets 25 mgAscend Laboratories is recalling 25 mg Metoprolol Succinate Extended-Release Tablets due to failed dissolution testing.
FDA•MODERATEBuprenorphine Hydrochloride Injection 0.3mg/mLEndo USA recalls Buprenorphine Hydrochloride Injection 0.3mg/mL vials (NDC 42023-179-05) due to particulate matter contamination.
FDA•MODERATEOasis Tears PF Lubricant Eye DropsOasis Tears PF eye drops (NDC 42126-6400-1) recalled due to lack of assurance of sterility.
FDA•MODERATEDuloxetine Delayed-Release Capsules 60mgBreckenridge Pharmaceutical is recalling Duloxetine 60mg capsules distributed nationwide due to the presence of an impurity above FDA limits.
FDA•MODERATENaproxen Oral SuspensionAcella Pharmaceuticals is recalling Naproxen Oral Suspension, 125 mg/5mL, distributed nationwide due to lead and lithium contamination.
FDA•MODERATEAmoxicillin and Clavulanate Potassium Oral Suspension DropsCronus Pharma is recalling Amoxicillin and Clavulanate Potassium oral suspension drops for dogs and cats due to product discoloration.
2 products
FDA•MODERATEOctreotide Acetate for Injectable SuspensionTeva is recalling Octreotide Acetate 30 mg injection kits due to a lack of assurance of sterility.
2 products
FDA•MODERATEEnalapril Maleate Tablets, USP 20 mgRising Pharma is recalling Enalapril Maleate 20 mg tablets (NDC 64980-688-10) due to failed impurities test.
FDA•MODERATEBD PurPrep Sterile SolutionCareFusion is recalling BD PurPrep sterile solution due to a lack of assurance of sterility and potential product contamination.
2 products
FDA•MODERATEDELFLEX Peritoneal Dialysis SolutionFresenius recalls DELFLEX PD solution 2L 5PK over potential sterility-compromising leaks.
2 products
FDA•MODERATEDuloxetine Delayed-Release Capsules 30 mgAjanta Pharma recalls Duloxetine 30 mg capsules due to N-nitroso-Duloxetine impurity above FDA limit.
3 products
FDA•MODERATEAlendronate Sodium Oral Solution 70 mg/75 mLHikma is recalling Alendronate Sodium Oral Solution 70 mg/75 mL (NDC 0054-0282-59) due to out-of-specification assay results.
FDA•MODERATEFreshKote Lubricant EyedropsHarrow Eye LLC is recalling FreshKote Lubricant Eyedrops (0.33 fl oz) due to lack of assurance of sterility.
FDA•MODERATEOptase Dry Eye Intense DropsScope Health is recalling Optase Dry Eye Intense Drops (0.33 fl oz, NDC 72972-002-01) due to lack of assurance of sterility.
FDA•MODERATEiVIZIA Sterile Lubricant Eye DropsThea Pharma is recalling iVIZIA Sterile Lubricant Eye Drops due to a lack of assurance of sterility.
2 products
FDA•MODERATEWells Pharma of Houston: multiple drugsWells Pharma recalls injectable solutions (phenylephrine, fentanyl, ketamine) over cGMP deviations.
7 products
FDA•MODERATEAlcon Research: Multiple Lubricant Eye Gel ProductsAlcon recalls Systane and GenTeal eye gels over sterility concerns.
2 products
FDA•MODERATEOmega-3-Acid Ethyl Esters CapsulesMajor Pharmaceuticals is recalling Omega-3-Acid Ethyl Esters Capsules due to failed stability testing for capsule shell loss on drying.
FDA•MODERATEB. Braun Sterile Water for Injection 3000 mL BagsB. Braun recalls Sterile Water for Injection 3000 mL bags over sterility concerns from potential port leakage.
4 products
FDA•MODERATESkin Script Blemish Spot TreatmentSkin Script Blemish Spot Treatment recalled over failed stability specifications; UPC 6 10563 13873 9.
FDA•MODERATEFurosemide Tablets, USP 80 mgLeading Pharma is recalling Furosemide Tablets 80 mg (NDC 69315-118-01) due to N-nitroso-Furosemide above recommended limits.
FDA•MODERATEClaravis (isotretinoin capsule, USP) 10 mgTeva is recalling Claravis 10 mg capsules (NDC 0555-1054-56, 0555-1054-86) due to out-of-specification Tretinoin impurity levels.
3 products
FDA•MODERATEMemantine Hydrochloride Extended-Release CapsulesMajor Pharmaceuticals is recalling 7 mg Memantine Hydrochloride Extended-Release Capsules due to failed dissolution specifications.
FDA•MODERATEPantoprazole Sodium Delayed-Release Tablets 40 mgCamber Pharmaceuticals is recalling Pantoprazole Sodium 40 mg tablets (NDC 31722-713-10) due to discoloration.
FDA•MODERATEDesmopressin Nasal Spray, USP 10 mcg/0.1 mLApotex is recalling Desmopressin Nasal Spray (NDC 60505-0815-0) due to defective bottle caps with missing or dislodged liners.
3 products
FDA•MODERATEEpinephrine Injection USP 1 mg/10mLInternational Medication Systems is recalling Epinephrine Injection 1 mg/10mL (NDC 76329-3318-1) due to lack of sterility assurance.
FDA•MODERATEClonidine Transdermal System 0.2 mg/dayTeva recalls Clonidine Transdermal System 0.2 mg/day over CGMP deviations from unapproved raw material.
3 products
FDA•MODERATEHuons Co: Multiple Rx Only ProductsHuons recalls Lidocaine HCl 1% vials and other injectables over sterility concerns.
9 products
FDA•MODERATEAlbuterol Sulfate Inhalation Solution 0.5%Nephron SC recalling Albuterol Sulfate Inhalation Solution (NDC 69374-330-05) due to illegible labeling.
FDA•MODERATEFluocinonide Cream 0.05%Taro recalls Fluocinonide Cream 0.05% 15g tubes due to failed viscosity specs.
3 products
FDA•MODERATESemaglutide-Glycine-Cyanocobalamin InjectableNorthwest Compounders is recalling Semaglutide-Glycine-Cyanocobalamin Injectable vials due to lack of assurance of sterility.
FDA•MODERATEFarmHouse Fresh Midnight Clearing Night LotionFarmHouse Fresh Night Lotion recalled due to benzene contamination.
4 products
FDA•MODERATECinacalcet Hydrochloride TabletsCipla recalls Cinacalcet HCl tablets over CGMP deviations and nitrosamine impurity.
3 products