FDA•MODERATE
Cimzia Prefilled Syringes
UCB is recalling Cimzia prefilled syringes and starter kits due to a lack of assurance of sterility.
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Drugs Recalls
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FDA•MODERATEErythromycin Tablets 250 mgZydus recalls Erythromycin 250 mg tablets due to 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•LOWPrimidone Tablets 250 mgAmerican Health Packaging recalls Primidone Tablets 250 mg due to trace Acemetacin contamination.
2 products
FDA•LOWBusulfan InjectionSagent Pharmaceuticals is recalling Busulfan Injection (NDC 25021-241-10) due to failed impurities and degradation specifications.
FDA•LOWPrimidone Tablets 50 mgPrimidone 50 mg tablets recalled due to possible cross-contamination with Acemetacin.
2 products
FDA•LOWPrimidone 250mg TabletsLannett Company is recalling Primidone 250mg Tablets (NDC 0527-1231-01) due to potential cross-contamination with Acemetacin API.
FDA•CRITICALDOXOrubicin Hydrochloride Liposome InjectionSun Pharma recalls DOXOrubicin Liposome Injection 50 mg/25 mL vials due to glass particulate matter.
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•CRITICALMG217 Multi-Symptom Treatment CreamMG217 Multi-Symptom Treatment Cream recalled due to Staphylococcus aureus 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•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 dialysis solution due to potential bag leaks compromising sterility.
2 products
FDA•MODERATEDuloxetine Delayed-Release Capsules 30 mgAjanta recalls Duloxetine 30 mg capsules over nitrosamine impurity above FDA limit.
3 products
FDA•LOWBuspirone Hydrochloride TabletsUnichem is recalling 5 mg buspirone hydrochloride tablets due to subpotency, which may reduce the medication's effectiveness.
FDA•LOWCVS Lidocaine Wound GelCVS is recalling Lidocaine Wound Gel (NDC 59898-950, 0.5 oz) due to failed pH specifications.
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•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•LOWLevocarnitine Injection, USPAmerican Regent is recalling Levocarnitine Injection, USP, 1 g/5 mL single-dose vials due to missing labels.
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•LOWMonsel's Ferric Subsulfate Solution 8 mLPremier Dental Products is recalling Monsel's Ferric Subsulfate Solution 8 mL vials (NDC 48783-112-08) due to incorrect expiration date on the vial label.
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•LOWMagnesium Chloride 6-Hydrate Crystal 500GAvantor is recalling Magnesium Chloride 6-Hydrate Crystal 500G bottles (NDC 10106-2448-1) due to subpotency.
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•MODERATEHuons: Multiple Rx Only InjectionsHuons recalls injectable lidocaine, bupivacaine, and saline due to sterility concerns.
9 products
FDA•LOWIsland Kinetics: multiple gelsIsland Kinetics recalls hydrocortisone 1% gels (Remedy Gel, Skin Rehab, Essential Calming) due to subpotency.
3 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•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