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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 […]
February 12, 2025

Cefepime – Injection products

Exceptions or additions to the recognized standards For the bacteria listed below, susceptibility test interpretive criteria are not recognized at this time: Acinetobacter spp Other Non-Enterobacterales […]
February 12, 2025

Azithromycin – Oral, Injection products

Exceptions or additions to the recognized standards   Minimum Inhibitory Concentrations(mcg/mL) S I R Neisseria gonorrhoeae – ≤1 ≥2 Abbreviations: S = Susceptible; I = Intermediate; […]