[9] FDA. Drug recalls[EB/ OL]. [2022 - 10 - 18]. https:/ / www.fda. gov/ drugs/ drug⁃safety⁃ and⁃availability/ drug⁃recalls. [10] 国家药典委员会. 中华人民共和国药典[S]. 2020 年版. 四部. 北京:中国医药科技出版社, 2020:2 -5. [11] USP. Injections and Implanted Dru...
[8] 郭艳争. 小容量注射剂可见异物影响因素分析和处理措施[J]. 当代化工研究, 2016(3):7 -8. [9] FDA. Drug recalls[EB/ OL]. [2022 - 10 - 18]. https:/ / www.fda. gov/ drugs/ drug⁃safety⁃ and⁃availability/ drug⁃recalls. [10] 国家药典委员会. 中华人民共和国药典[S]. 202...
The Food and Drug Administration (FDA) deemed a recall of theAsensus SurgicalSenhance surgical robot as Class I, the most serious kind. Asensus recalled its Senhance system due to malfunctions causing unintended movement of the robotically-assisted surgical device. The issue presented itself as an...
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4.召回(recalls) FDA有权要求企业或个人对已经流入市场的违法违规产品实施召回。召回分为强制召回和主动召回,多数召回为主动召回。除非产品的公共危害严重或者情况紧急,FDA一般不会对药品实施强制召回。因为一旦FDA发出药品的强制召回,法律就给被召回者提供面见FDA主要官...
FDA Recalls Three Versions of Drug.doi:10.1097/00000446-197906000-00010&NA&NAAjn the American Journal of Nursing
For over-the-counter (OTC) NSAIDs intended for use in adults, FDA will also update the Drug Facts labels. These labels already warn to avoid using NSAIDs during the last 3 months of pregnancy because the medicines may cause problems in the unborn child or complications during delivery. The...
Drug Safety Communication: All Opioid Pain Medicines - FDA Updates Prescribing Information to Provide Additional Guidance for Safe Use Apr 13, 2023 | Audience: Patient, Health Professional, Pain Management, Pharmacy, Caregivers ISSUE: The FDA is requiring several updates to theprescribing inf...
The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories.
A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls. 各留样批次检验结果摘要。如果检验表明药品质量不合格,请采取迅速的纠正措施,例如通知客户...