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June 15, 2020

Duy Drugs Inc. – 542933 – 05/27/2020

Delivery Method: Electronic Mail Reference #: 20-HAFE4-WLCOL-12 Product: Dietary SupplementsDrugs Recipient: Recipient Name Mr. Ricardo Mayo-Alvarez Recipient Title President/Owner Duy Drugs Inc. 1730 NW 79th Ave.Doral, […]
June 15, 2020

Duy Drugs Inc. – 542933 – 08/28/2018

Delivery Method: United Parcel Service Reference #: 18-HAFE4-WL-05 Product: Dietary SupplementsDrugs Recipient: Recipient Name Mr. Ricardo Mayo-Alvarez Recipient Title President/Owner Duy Drugs Inc. 1730 NW 79th […]
June 13, 2020

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)

Summary Company Announcement Date: June 11, 2020 FDA Publish Date: June 11, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Detection of N-Nitrosodimethylamine (NDMA) […]
June 13, 2020

Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Ibuprofen Lysine Injection, 20 Mg/2 Ml (10 Mg/Ml) Due to Particulate Matter

Summary Company Announcement Date: February 08, 2017 FDA Publish Date: February 08, 2018 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Some of the […]
June 12, 2020

Galt Pharmaceuticals LLC – 593156 – 06/03/2020

Product: Drugs Recipient: Recipient Name Manoj Amaraneni Recipient Title Regulatory Affairs Officer Galt Pharmaceuticals LLC 3350 Riverwood ParkwaySuite 1900Atlanta, GA 30339United States Issuing Office: Division of […]
June 12, 2020

Galt Pharmaceuticals LLC – 593156 – 09/13/2019

Delivery Method: Facsimile Product: Drugs Recipient: Recipient Name Bharat Patel, Pharm.D. Recipient Title CEO and Co-Founder Galt Pharmaceuticals LLC 3350 Riverwood Parkway, Suite 1900Atlanta, GA 30339United […]
June 12, 2020

Clinical Outcome Assessments (COA) Qualification Program Resources

Below we provide resources to assist requestors and those interested in the CDER COA Qualification Program. If you have questions, please contact the CDER COA Qualification […]
June 12, 2020

Jubilant DraxImage Radiopharmacies, Inc. – 480877 – 06/04/2020

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Wayne Alexander, MBA Recipient Title Director, Quality Jubilant DraxImage Radiopharmacies, Inc. Triad Isotopes Inc. 4205 Vineland […]
June 12, 2020

Central Admixture Pharmacy Services Inc – 497021 – 05/27/2020

Product: Drugs Recipient: Recipient Name Thomas J. Wilverding Recipient Title President Central Admixture Pharmacy Services Inc 6800 Aston StreetSuite 150Irvine, CA 92606United States Issuing Office: Division […]
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