MODESTO, CA, July 29, 2025 – High Noon is recalling two production lots of High Noon Beach Variety packs (12-pack/12 fluid ounce cans). Some of these packs contain cans that are filled with High Noon vodka seltzer alcohol and are mislabeled as CELSIUS® ASTRO VIBE™ Energy Drink, Sparkling Blue Razz E
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Biosimilars Action Plan
FDA is committed to encouraging innovation and competition for biologics and facilitating the development of safe and effective biosimilars.Model-Informed Drug Development Paired Meeting Program
FDA is conducting a MIDD Pilot Program to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources, referred to as MIDD approaches.FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary
FDA-TRACK: Prescription Drug User Fee Act Meeting Goals SummaryStokes Healthcare Inc. dba Epicur Pharma. Mount Laurel, NJ. 483 issued 05/23/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 05/23/2025
Short Title (70 char) Stokes Healthcare Inc. dba Epicur Pharma. Mount Laurel, NJ. 483 issued 05/23/2025
FEI Number 3002815949
Firm Name Stokes Healthcare Inc. dba Epicur Pharma
Record Type 483
State NResources for Biomarker Requestors
Information and resources for requestors about FDA’s Biomarker Qualification ProgramUPDATE – Sandoz Inc. Issues Voluntary Nationwide Recall Expansion of One Additional Lot of Cefazolin for Injection Due to Product Mislabeling
Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot is being recalled due to a customer complaint indicating that four (4) vials incorrectly labelled as Penicillin G Potassium for Injection, USP