FDA•MODERATE
Alendronate Sodium Oral Solution 70 mg/75 mL
Hikma is recalling Alendronate Sodium Oral Solution 70 mg/75 mL (NDC 0054-0282-59) due to out-of-specification assay results.
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Drugs Recalls
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FDA•CRITICALLactated Ringer's Injection USPB. Braun Medical is recalling Lactated Ringer's Injection USP due to the presence of particulate matter.
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•MODERATEThea Pharma: Multiple Sterile Lubricant Eye DropsThea Pharma recalls iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%) over sterility concerns from CGMP deviations.
2 products
FDA•MODERATEWells Pharma of Houston: multiple injectionsWells Pharma recalls injectable drugs (phenylephrine, fentanyl, ketamine) over cGMP deviations.
7 products
FDA•MODERATEAlcon Research: Multiple Lubricant Eye GelsAlcon 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•CRITICALHeritage Animal Nutrition Medicated FeedHeritage Animal Nutrition is recalling 50 lb bags of medicated feed due to potential rumensin contamination.
FDA•MODERATEB. Braun Sterile Water for Injection 3000 mLB. Braun recalls Sterile Water for Injection 3000 mL bags over sterility and leakage risk.
4 products
FDA•MODERATEFreshKote Lubricant EyedropsHarrow Eye LLC is recalling FreshKote Lubricant Eyedrops (0.33 fl oz) due to lack of assurance of sterility.
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 due to CGMP deviations (unapproved raw material).
3 products
FDA•MODERATEHuons: Multiple Rx Only InjectionsHuons recalls injectable lidocaine, bupivacaine, and saline due to 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 0.05% Cream 15gTaro recalls Fluocinonide 0.05% Cream 15g tubes due to out-of-spec viscosity.
3 products
FDA•MODERATESemaglutide-Glycine-Cyanocobalamin InjectableNorthwest Compounders is recalling Semaglutide-Glycine-Cyanocobalamin Injectable vials due to lack of assurance of sterility.
FDA•MODERATEHydroPeptide Clear Alliance SerumHydroPeptide Clear Alliance Serum recalled due to benzene contamination.
4 products
FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets over N-Nitroso impurity above acceptable limit.
3 products
FDA•MODERATEExchange Select Honey Lemon Cough DropsExchange Select Honey Lemon Cough Drops recalled over quality concerns from FDA inspection.
15 products
FDA•MODERATELanreotide Injection 120 mg/0.5 mLCipla recalls Lanreotide Injection 120 mg/0.5 mL over sterility assurance concerns.
2 products
FDA•MODERATEOmnipaque (iohexol) Injection 350 mg/mLGE Healthcare recalls Omnipaque (iohexol) Injection 350 mg/mL due to particulate matter.
2 products
FDA•CRITICALBlaine Labs: multiple drugsBlaine Labs recalls multiple topical antiseptic/antifungal gels and creams due to Lysinibacillus fusiformis contamination.
9 products
FDA•MODERATEXanax XR Alprazolam 3 mg TabletsViatris is recalling Xanax XR 3 mg tablets (NDC 58151-506-91) due to failed dissolution specifications.
FDA•MODERATEIsotretinoin Capsules, USP, 40 mgTeva is recalling 40 mg Isotretinoin Capsules due to potency issues.
2 products
FDA•MODERATEVancomycin HCl 1.5g in 250mL Sodium Chloride InjectionFagron recalls Vancomycin HCl 1.5g/250mL injection due to sterility concern.
5 products
FDA•MODERATEGeri-Care Artificial Tears Lubricant Eye DropsGeri-Care Artificial Tears Lubricant Eye Drops (0.5 oz, NDC 68788-7266-0) recalled due to lack of sterility assurance.
FDA•MODERATEFresenius Kabi: Multiple Sale NDC Number InjectionsFresenius Kabi recalls 14 lots of Sodium Chloride and Dextrose Injections due to sterility concerns.
14 products
FDA•MODERATEMeclizine Hydrochloride Tablets 12.5 mgAmerican Health Packaging is recalling Meclizine Hydrochloride 12.5 mg tablets (NDC 60687-775-65 and 60687-775-11) due to failed tablet specifications.
FDA•MODERATEPrazosin Hydrochloride Capsules 1mgAppco Pharma recalls Prazosin HCl 1mg capsules over nitrosamine impurity (NNP) above acceptable limits.
3 products
FDA•MODERATEK.C. Pharmaceuticals: Multiple Eye DropsK.C. Pharmaceuticals recalls multiple brands of sterile eye drops over sterility concerns.
15 products
FDA•MODERATEBromfenac Ophthalmic Solution 0.07%Alembic Pharmaceuticals is recalling Bromfenac Ophthalmic Solution 0.07% (NDC 62332-583-03) due to failed impurities and degradation specifications.
FDA•MODERATETramadol Hydrochloride Tablets 50 mgAmneal is recalling 500-count bottles of Tramadol Hydrochloride 50 mg tablets due to an impurity found during stability testing.
FDA•MODERATECurosurf (poractant alfa) 240 mg Intratracheal SuspensionChiesi USA is recalling Curosurf 240 mg intratracheal suspension vials (NDC 10122-510-03) due to lack of sterility assurance.
FDA•MODERATEOctreotide Acetate Injectable Suspension 20 mgTeva recalls Octreotide Acetate 20 mg vials over sterility assurance concerns.
6 products
FDA•MODERATENoromycin 300 LA Oxytetracycline InjectionMWI Animal Health is recalling Noromycin 300 LA oxytetracycline injection (NADA# 141-143) due to lack of assurance of sterility.
FDA•MODERATEBrimonidine Tartrate/Timolol Maleate Ophthalmic SolutionApotex is recalling Brimonidine Tartrate/Timolol Maleate eye drops (NDC 60505-0589-1) due to lack of sterility assurance.
FDA•CRITICALMagnesium Sulfate in Water for Injection IV BagsAmneal recalls Magnesium Sulfate IV bags due to product mix-up with Tranexamic Acid.
FDA•MODERATELevothyroxine Sodium Tablets USP 150 mcgMacleods Pharma recalls Levothyroxine Sodium 150 mcg tablets (NDC 33342-401-44) nationwide due to subpotency.
FDA•MODERATEDexamethasone Sodium Phosphate Injection, USP 100 mg/10 mLSomerset Therapeutics is recalling Dexamethasone Sodium Phosphate Injection (NDC 70069-025-10/01) due to out-of-specification impurities at expiry.
FDA•MODERATEIcosapent Ethyl CapsulesZydus Pharmaceuticals is recalling Icosapent Ethyl Capsules due to oxidation, which can cause capsule melting and discoloration.
FDA•CRITICALWebcol Alcohol Prep Pads (70% Isopropyl Alcohol)Cardinal Health is recalling Webcol Alcohol Prep Pads (200-count boxes) due to microbial contamination that may pose infection risk.
3 products
FDA•MODERATEBioCox 60 Type A Medicated ArticleHuvepharma is recalling BioCox 60 Type A Medicated Article due to failure to meet stability specification requirements.
FDA•MODERATEChildren's Ibuprofen Oral Suspension 100 mg/5mLTaro Pharmaceuticals is recalling Children's Ibuprofen Oral Suspension 100 mg/5mL (120 mL) due to gel-like masses and black particles.
FDA•CRITICALBlue Bull Extreme Male Enhancement SupplementBlue Bull Extreme Male Enhancement recalled due to undeclared sildenafil.
3 products