FDA•MODERATE
Mycophenolate Mofetil for Injection
Mylan recalls Mycophenolate Mofetil for injection, 500 mg/vial, over failed dissolution specs.
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FDA•MODERATEtraZODone Hydrochloride Tablets, USP, 50 mgTeva recalls traZODone HCl 50 mg tablets due to foreign tablets/capsules in product.
FDA•MODERATEPooled Cryoprecipitated AHFVitalant recalls Pooled Cryoprecipitated AHF for not meeting specifications.
FDA•MODERATELexia: Multiple Broadway Joe's Pain CreamsLexia LLC recalls Broadway Joe's Pain Cream over potential raw material contamination.
2 products
FDA•MODERATEApheresis Platelets, Leukocytes Reduced, IrradiatedNew York Blood Center Enterprises recalls Apheresis Platelets, Leukocytes Reduced, Irradiated units over excessive platelet count.
FDA•MODERATEPrasugrel Tablets 10mgMylan recalls Prasugrel Tablets 10mg over failed dissolution specs.
FDA•MODERATETHE ONE SPF 50 Invisible Sunscreen GelAllies Group recalls THE ONE SPF 50 Invisible Sunscreen Gel over subpotent protection.
4 products
FDA•MODERATEBaxter Healthcare: multiple drugsBaxter recalls 17 sterile injectable drugs, including Vancomycin and Clindamycin, over CGMP deviations.
17 products
FDA•MODERATEApheresis Platelets, PAS, Leukocytes Reduced, Pathogen ReducedRed Cross recalls Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced, not tested for pH.
FDA•MODERATEPaxil CR Paroxetine 37.5mg TabletsApotex recalls Paxil CR 37.5mg tablets for failing dissolution specs.
FDA•MODERATERamipril Capsules USP 10 mgHikma recalls Ramipril Capsules USP 10 mg over a failed impurity (DCU) specification.
FDA•MODERATEZicam Medicated Nasal SwabsZicam nasal swabs recalled over microbiological testing failures.
FDA•MODERATEActhar Gel (Repository Corticotropin Injection) 5 mL VialsMallinckrodt recalls Acthar Gel 5 mL vials over glass and stopper particulate.
2 products
FDA•MODERATEClobetasol Propionate Cream USP, 0.05%Lupin recalls Clobetasol Propionate Cream 0.05% due to failed content uniformity.
FDA•CRITICALBaxter Dextrose Injection 70% 2000 mL BagsBaxter recalls Dextrose Injection 70% 2000 mL bags over stainless steel particles.
FDA•CRITICALTyenne (tocilizumab-aazg) Injection 400 mg/20 mLFresenius Kabi recalls Tyenne ( (tocilizumab-aazg) 400 mg/20 mL vials over glass particles.
FDA•MODERATERemedy+ Recovery Dogswell Pet WormerRemedy+ Recovery Dogswell Pet Wormer recalled due to adverse event complaints.
FDA•MODERATELevothyroxine Sodium Tablets 25 mcgAccord recalls Levothyroxine 25 mcg tablets due to subpotency.
12 products
FDA•CRITICALLactated Ringer's Injection USP 1000 mLB. Braun recalls Lactated Ringer's Injection 1000 mL over particulate matter.
FDA•MODERATECarbamazepine Tablets 200mgGSMS recalls Carbamazepine 200mg tablets over black specks.
FDA•MODERATEAcamprosate Calcium 333 mg TabletsMylan recalls Acamprosate Calcium 333 mg tablets over dissolution failure.
FDA•MODERATEWhole BloodSuncoast Communities Blood Bank recalls whole blood due to incomplete donor eligibility screening.
2 products
FDA•CRITICALKian Pee Wan CapsulesBuy-Herbal recalls Kian Pee Wan Capsules due to undeclared dexamethasone and cyproheptadine.
FDA•MODERATECarbamazepine Tablets 200mgTaro recalls Carbamazepine 200mg tablets over black specks.
2 products
FDA•MODERATERed Blood Cells, Leukocytes ReducedOneBlood recalls Red Blood Cells, Leukocytes Reduced from a misregistered donor.
FDA•MODERATEPEMRYDI RTU Pemetrexed InjectionShilpa Medicare recalls PEMRYDI RTU vials over green discoloration.
2 products
FDA•MODERATELibtayo (cemiplimab-rwlc) InjectionRegeneron recalls Libtayo (cemiplimab-rwlc) Injection 350 mg/7 mL over sterility concerns.
FDA•MODERATEShoolin Pharma Chem: multiple drugsShoolin Pharma Chem recalls Sildenafil and Tadalafil APIs due to CGMP deviations.
5 products
FDA•MODERATEClear Eyes Maximum Itchy Eye ReliefClear Eyes Maximum Itchy Eye Relief recalled over potential sterility issues.
- FDA•MODERATERed Blood Cells, Leukocytes Reduced
Red blood cell units distributed after donor tested reactive for hepatitis C antibody.
- FDA•MODERATERed Blood Cells, Leukocytes Reduced
Hoxworth recalls Red Blood Cells, Leukocytes Reduced due to malaria risk from donor travel.
- FDA•MODERATEApheresis Red Blood Cells, Leukocytes Reduced
LifeShare Blood Centers recalls apheresis red blood cells, leukocytes reduced, from a donor with incomplete eligibility screening.
FDA•MODERATERed Blood Cells, Leukocytes ReducedLifeShare distributed leukoreduced red blood cells from a malaria-endemic-area donor.
FDA•CRITICALMorphine Sulfate Injection 2 mg/mL Prefilled SyringesFresenius Kabi recalls Morphine Sulfate 2 mg/mL syringes over a label mixup that may contain Dilaudid.
2 products
FDA•MODERATEClindamycin Palmitate Hydrochloride Oral SolutionAvet recalls Clindamycin Palmitate Oral Solution 75 mg/5 mL over particles and white flakes.
- FDA•MODERATERed Blood Cells, Leukocytes Reduced
Hoxworth Blood Center recalls Red Blood Cells, Leukocytes Reduced over malaria risk.
FDA•MODERATEDiovan (valsartan) 160 mg TabletsNovartis recalls Diovan (valsartan) 160 mg tablets due to failed dissolution specs.
FDA•MODERATESemaglutide 12.5mg Multi-Dose VialApollo Care recalls semaglutide 12.5mg vials due to particulate matter.
11 products- FDA•MODERATEApheresis Platelets, Leukocytes Reduced
Suncoast Blood Bank recalls apheresis platelets from a donor with recent malaria-area travel.
FDA•MODERATEMirabegron Extended-Release Tablets 25 mgZydus recalls Mirabegron ER 25 mg tablets over nitrosamine impurity.
FDA•CRITICALGlutathione 200 mg/mL InjectionVictory Medical Center Pharmacy recalls Glutathione 200 mg/mL vials over bacterial endotoxin contamination.
- FDA•MODERATERed Blood Cells, Leukocytes Reduced
Rhode Island Blood Center recalls Red Blood Cells, Leukocytes Reduced units from a malaria-endemic-area donor.
FDA•MODERATEDicyclomine Hydrochloride Capsules 10mgAurobindo recalls Dicyclomine HCl 10mg capsules due to shortfill and empty capsules.
FDA•MODERATEAmerican Regent: multiple injectionsAmerican Regent recalls Adequan injections due to particulate matter including glass.
2 products
FDA•CRITICALOptiray 350 Ioversol InjectionLiebel-Flarsheim recalls Optiray 350 Ioversol Injection 500 mL vials due to particulate matter (plastic, steel, glass).
2 products
FDA•MODERATEAzelaic Acid Gel 15%Glenmark recalls Azelaic Acid Gel 15% over grainy/gritty texture complaints.
FDA•CRITICALRelax 5-HTP Plus Vitamin B6Relax 5-HTP Plus Vitamin B6 recalled for elevated 5-HTP levels above allowed dosage.
2 products
FDA•CRITICALCefazolin in Dextrose InjectionBaxter recalls Cefazolin in Dextrose 2g/100mL infusion bags due to particulate matter.
FDA•CRITICALAmerican Regent: Multiple Packaged In InjectionsAmerican Regent recalls Nitroglycerin Injection 50 mg/10 mL and other injectables due to particulate matter (hair).
14 products
FDA•MODERATEDorzolamide HCl and Timolol Maleate Ophthalmic SolutionMicro Labs recalls Dorzolamide HCl/Timolol Maleate 2%/0.5% 10mL ophthalmic solution due to defective container caps.