FDA openFDA Drug Enforcement (recalls)·· 7 天前AI 评分50
Brandywine Pharmaceuticals 召回 Theophylline Extended-Release Tablets 100 mg
Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10
AI 导读
Brandywine Pharmaceuticals, LLC 召回 100 mg Theophylline Extended-Release Tablets。召回原因为第三方实验室进行的持续稳定性测试程序中断，导致 CGMP 偏差。
来源：FDA openFDA Drug Enforcement (recalls) · api.fda.gov