FDA•
Cyclophosphamide for Injection
Sunny Pharmtech recalls Cyclophosphamide for Injection over steel particulate matter in 3 lots.
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Drugs Recalls
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FDA•Cefazolin in Dextrose Injection 2g/100mLBaxter recalls Cefazolin in Dextrose Injection 2g/100mL over particulate matter (cardboard) in solution.
FDA•Papaverine Hydrochloride Injection 60 mg/2 mLAmerican Regent recalls Papaverine HCl Injection 60 mg/2 mL over visible particulate matter.
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.
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.