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February 14, 2025

Individual Case Safety Reports

Description:  The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use […]
February 13, 2025

Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results at the 12-month Stability Time Point

Summary Company Announcement Date: July 29, 2023 FDA Publish Date: July 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Out of Specification Results […]
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