FDA•
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill
B. Braun recalls 0.9% Sodium Chloride Injection, 100 mL Partial Fill, due to particulate matter (iron oxide, cellulose, polystyrene).
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FDA•fentaNYL Citrate Injection 1,000 mcg/100 mLOurPharma recalls fentaNYL Citrate Injection 1,000 mcg/100 mL over mislabeled expiry dates; NDC 73013-1013-01.
FDA•Epinephrine Injection 30 mg/30 mLAmerican Regent recalls epinephrine 30 mg/30 mL vials due to glass particulates and sterility concerns.
FDA•MODERATEMycophenolate Mofetil for InjectionMylan recalls Mycophenolate Mofetil for injection, 500 mg/vial, over failed dissolution specs.
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•2% Chlorhexidine Gluconate ClothsSage Products recalls 2% Chlorhexidine Gluconate Cloths over possible cross-contamination.
FDA•Buprenorphine Sublingual Tablets 2 mgAmerican Health Packaging recalls Buprenorphine Sublingual Tablets 2 mg over a label mix-up.
FDA•MODERATEApheresis Platelets, Leukocytes Reduced, IrradiatedNew York Blood Center Enterprises recalls Apheresis Platelets, Leukocytes Reduced, Irradiated units over excessive platelet count.
FDA•Prasugrel HCl 10mg TabletsGSMS recalls Prasugrel HCl 10mg tablets over failed dissolution specs.
FDA•Revcovi (elapegademase-lvlr) InjectionChiesi USA recalls Revcovi ( elapegademase-lvlr) Injection over failed stability specifications.
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•Baxter 0.9% Sodium Chloride Injection 500 mLBaxter recalls 0.9% Sodium Chloride Injection 500 mL VIAFLEX bags over fiberglass particulate contamination.
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•Glutathione 200 mg/mL Sterile Multidose VialsOptimal Balance Pharmacy recalls Glutathione 200 mg/mL vials over bacterial endotoxin contamination.
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.