Wednesday, December 25, 2024

Wednesday, December 25, 2024

6 drugs recalled during June, FDA reports


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Six drugs were recalled in June to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.

Such recalls are voluntary actions carried out by drug makers to remove potentially defective medicines from the market, the FDA said. They may be initiated either by the manufacturer or the FDA.

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Drug Recalls for June

DateBrand NameProduct DescriptionReason/ ProblemCompany
June 28PharMEDium0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD SyringeThe electronic customer ordering system stated it is sulfite-free, but the product contains sulfite.PharMEDium Services LLC
June 26MacleodsLosartan Potassium USP tablets and Losartan Potassium/Hydrochlorothiazide combination tabletsPresence of NMBA impurityMacleods Pharmaceutical Limited
June 20Infusion Options Inc.All sterile products within expiryLack of Sterility AssuranceInfusion Options Inc.
June 18Premier Pharmacy LabsAll products intended to be sterileLack of Sterility AssurancePremier Pharmacy Labs Inc.
June 18RXQ Compounding LLCAll sterile human and animal products within expiryLack of Sterility Process AssuranceRXQ Compounding LLC
June 11GSMS Inc.Losartan potassium tabletsDetection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)Teva Pharmaceuticals USA Inc.
Source: U.S. Food and Drug Administration

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