FDA•MODERATE
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Micro Labs recalls Dorzolamide HCl/Timolol Maleate 2%/0.5% 10mL ophthalmic solution due to defective container caps.
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Drugs Recalls
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FDA•Proin ER TabletsPegasus recalls Proin ER 145mg tablets for dogs due to failed dissolution specs.
FDA•Ascend Laboratories: Multiple Dabigatran Etexilate CapsulesAscend recalls Dabigatran Etexilate Capsules (150 mg, 75 mg) over impurity/degradation failures.
3 products
FDA•Mycophenolate Mofetil for InjectionMylan recalls Mycophenolate Mofetil for Injection 500 mg vials due to precipitate.
FDA•MODERATEFresenius Kabi: Multiple Rx Only ProductsFresenius Kabi recalls multiple injectable drugs due to hair found in product.
5 products
FDA•MODERATERohto-Mentholatum (Vietnam) Co: multiple drugsRohto-Mentholatum recalls multiple Rohto Cooling Eye Drops over sterility concerns.
8 products
FDA•Glycopyrrolate Oral SolutionPrecision Dose recalls Glycopyrrolate Oral Solution over an unidentified impurity.
FDA•Cetirizine Hydrochloride Tablets 5 mgRising Pharma recalls Cetirizine HCl 5 mg tablets over Ranitidine cross-contamination.
FDA•MODERATEAXP Processing Bag SetThermoGenesis recalls AXP Processing Bag Set, Model 8-5101, over stopcock particulates in sterile fluid path.
FDA•LOWLidolog KitLidolog Kit is being recalled because the label wrap obscures the barcode, making it difficult to scan.
FDA•MODERATECyproheptadine Hydrochloride SyrupRising Pharma recalls Cyproheptadine HCl Syrup 2mg/5 mL due to crystallization and floating particles.
FDA•MODERATELevothyroxine Sodium 25 mcg TabletsMajor Pharmaceuticals is recalling Levothyroxine Sodium 25 mcg tablets due to subpotency.
12 products
FDA•MODERATEAmlodipine and Olmesartan Medoxomil TabletsAscend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (10 mg/20 mg) due to failed dissolution specifications.
FDA•Trokendi XR 25mg CapsulesSupernus Pharmaceuticals is recalling Trokendi XR 25mg capsules due to failed dissolution specifications.
- FDA•Ascend Laboratories: Multiple Dabigatran Etexilate Capsules
Ascend Laboratories is recalling 110 mg and 150 mg Dabigatran etexilate capsules due to failed impurity and degradation specifications.
2 products 
FDA•Divalproex Sodium Delayed-Release TabletsBionpharma is recalling 500 mg Divalproex Sodium Delayed-Release Tablets due to the presence of foreign tablets or capsules in the bottles.
FDA•MODERATEApheresis Platelets, Leukocytes Reduced, IrradiatedLifeSouth is recalling Apheresis Platelets, Leukocytes Reduced, Irradiated, due to failure to meet platelet yield specifications.
FDA•MODERATEBD ChloraPrep Clear ApplicatorsCareFusion is recalling BD ChloraPrep Clear sterile solution applicators due to a potential lack of sterility from incomplete packaging seals.
FDA•MODERATECleviprex Injectable EmulsionChiesi USA is recalling Cleviprex (clevidipine injectable emulsion) 50 mg/100 mL vials due to a lack of assurance of sterility.
FDA•MODERATEBell Pharmaceuticals: Multiple Carbamide Peroxide ProductsBell Pharmaceuticals recalls store-brand carbamide peroxide ear drops for subpotency (low pH, ~0.6% assay).
11 products
FDA•MODERATENystatin Cream USPPadagis is recalling 15 g tubes of Nystatin Cream USP due to subpotent drug results found during stability testing.
FDA•MODERATEPemetrexed for Injection 100mg/VialReliance Life Sciences recalls Pemetrexed for Injection 100mg/Vial over cGMP deviations.
4 products
FDA•MODERATEGasco Industrial: Multiple Isopropyl Alcohol ProductsGasco recalls Isopropyl Alcohol 70% in 16 oz, 32 oz, and 1 gal sizes due to subpotency.
6 products
FDA•LOWFexofenadine Hydrochloride Tablets 180 mgOhm Laboratories is recalling 180 mg Fexofenadine Hydrochloride tablets due to failed impurities and degradation specifications.
- FDA•MODERATEApheresis Platelets, Leukocytes Reduced, Irradiated
Vitalant is recalling Apheresis Platelets, Leukocytes Reduced, Irradiated due to missing white blood cell count verification testing.
FDA•MODERATEMethohexital Sodium 100 mg/10 mLQuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL vials due to failed impurities and degradation specifications.
FDA•MODERATEMedline Remedy Specialized Silicone CreamMedline Remedy Specialized Silicone Cream is recalled due to an out-of-specification result for formaldehyde in the raw material.
FDA•MODERATEClomiphene Citrate USP Active Pharmaceutical IngredientShimoga Chemicals is recalling Clomiphene Citrate USP Active Pharmaceutical Ingredient due to cGMP deviations.
FDA•MODERATEMethohexital Sodium for Injection 500 mgAvet Pharmaceuticals is recalling Methohexital Sodium for Injection 500 mg vials due to failed impurities and degradation specifications.
FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets over N-nitroso impurity above safe limit.
3 products
FDA•MODERATEDextroamphetamine/Amphetamine Extended-Release CapsulesLannett is recalling 5 mg Dextroamphetamine/Amphetamine ER capsules due to a labeling mix-up where capsules contain immediate-release pellets.
FDA•MODERATEAsclemed: Multiple Lidocaine Hcl Injection ProductsAsclemed recalls Accucaine kits and Lidocaine HCl injection ampules over sterility concerns.
2 products
FDA•MODERATEGlucagon Emergency KitLupin recalls Glucagon Emergency Kits due to a stability test failure that may impair emergency use.
3 products
FDA•MODERATEGemcitabine InjectionHikma is recalling Gemcitabine Injection due to improper temperature storage.
FDA•MODERATESynjardy XR TabletsBoehringer Ingelheim is recalling Synjardy XR tablets due to manufacturing deviations involving improper cleaning and sampling of production equipment.
FDA•MODERATELevothyroxine Sodium Tablets 300 mcgAccord Healthcare is recalling 300 mcg Levothyroxine Sodium Tablets due to subpotency.
FDA•MODERATEprednisoLONE Acetate Ophthalmic Suspension 1%Lupin Pharmaceuticals is recalling three sizes of prednisoLONE Acetate Ophthalmic Suspension 1% due to the presence of a foreign substance.
FDA•MODERATEImuldosa (ustekinumab-srlf) InjectionAccord BioPharma is recalling Imuldosa (ustekinumab-srlf) 130 mg/26 mL injection vials due to a lack of assurance of sterility.