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August 9, 2022
Published by Med Search on August 9, 2022
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[8/9/2022] FDA recently became aware of a nitrosamine impurity, Nitroso-STG-19 (known as NTTP), in certain samples of sitagliptin, a medicine used to treat type 2 diabetes […]
August 9, 2022
Published by Med Search on August 9, 2022
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Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER August 4, 2022 RE: 632509 To […]
August 9, 2022
Published by Med Search on August 9, 2022
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Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER August 4, 2022 RE: 631521 Dear […]
August 9, 2022
Published by Med Search on August 9, 2022
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Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER August 4, 2022 RE: 629452 Dear […]
August 8, 2022
Published by Med Search on August 8, 2022
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Delivery Method: Via Email Product: Dietary SupplementsDrugsFood & Beverages Recipient: Recipient Name Ms. Rena S. Greenberg Recipient Title Registered Agent Rena’s Organic 414 26th St WestBradenton, […]
August 5, 2022
Published by Med Search on August 5, 2022
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Human Compounding Fee Payment Instructions When are fees incurred?Beginning in fiscal year (FY) 2015, outsourcing facilities that register with the FDA may incur one or more […]
August 5, 2022
Published by Med Search on August 5, 2022
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Summary Company Announcement Date: November 08, 2019 FDA Publish Date: November 08, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company […]
August 5, 2022
Published by Med Search on August 5, 2022
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For Immediate Release: August 05, 2022 Today, the U.S. Food and Drug Administration approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable […]
August 5, 2022
Published by Med Search on August 5, 2022
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Product: Drugs Recipient: Recipient Name Arend John Kuijvenhoven FluxxLab LLC 1681 Niagara Rd.Montrose, CO 81401United States [email protected] WARNING LETTER RE: 637158 Date: August 4, 2022 TO: Arend […]
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