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December 27, 2022

Unit Dose Services, LLC – 636177 – 12/21/2022

Reference #: WL 2310 Product: Drugs Recipient: Recipient Name Peter Levasseur Unit Dose Services, LLC 20201 Northeast 16th PlaceMiami, FL 33179United States Issuing Office: Center for […]
December 27, 2022

Rite Aid Corporation – 643207 – 12/20/2022

Reference #: WL 2277 Product: Drugs Recipient: Recipient Name Elizabeth Hanlon Rite Aid Corporation 200 Newberry CommonsEtters, PA 17319United States Issuing Office: Center for Drug Evaluation […]
December 27, 2022

Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 Due to Product Mix-Up

Summary Company Announcement Date: December 23, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling Company Name: Accord […]
December 27, 2022

MD Pharmaceutical Supply, LLC – 637815 – 11/22/2022

Delivery Method: Email Product: Drugs Recipient: Recipient Name Mr. Richard J. Romeo Recipient Title Owner and President MD Pharmaceutical Supply, LLC P.O. Box 244Hanover, PA 17331-2921United […]
December 27, 2022

Green Pharmaceuticals Inc. – 635162 – 12/16/2022

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Ms. Dominique De Rivel Recipient Title President Green Pharmaceuticals Inc. 591 Constitution Ave Ste ACamarillo, […]
December 27, 2022

Mike Millenkamp Dairy Cattle – 640782 – 11/28/2022

Delivery Method: Certified Mail Product: Animal & VeterinaryDrugs Recipient: Recipient Name Michael T. Millenkamp Recipient Title Owner Mike Millenkamp Dairy Cattle 2065 137th StreetEarlville, IA 52041United […]
December 23, 2022

Plan B One-Step (1.5 mg levonorgestrel) Information

Plan B One-Step is an emergency contraceptive, a backup method of birth control. Emergency contraception is used to reduce the chance of pregnancy after unprotected sex […]
December 23, 2022

FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma

On December 22, 2022, the Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), a bispecific CD20-directed CD3 T-cell engager for adult […]
December 23, 2022

Overview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – 02/01/2023

On This Page Date: February 1, 2023 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR FDA […]
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