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1 Οκτ 2024 · Recalls, Market Withdrawals, & Safety Alerts. The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all...
- Enforcement Reports
FDA considers a recall to be a firm's removal or correction...
- Industry Guidance For Recalls
Public Warning and Notification of Recalls Under 21 CFR Part...
- Major Product Recalls
Recalls associated with Almark’s recall of hard-boiled egg...
- Archive for Recalls, Market Withdrawals & Safety Alerts
The Recalls, Market Withdrawals & Safety Alerts are...
- Enforcement Reports
EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee Briefing Document 3 Development of ximelagatran The efficacy and safety of ximelagatran has been studied in a broad range of thrombogenic states in large, worldwide, comparator-controlled, and primarily outcome-based clinical studies.
In this briefing document, AstraZeneca will provide the information necessary to make an assessment of the benefit-risk profile for ximelagatran as an oral anticoagulant and antithrombotic based on comparisons of ximelagatran to warfarin and to placebo.
29 Οκτ 2024 · Dr. Elder: Yes. A class I recall is the most serious, where there is a reasonable probability that using or being exposed to the recalled drug will cause serious adverse health consequences for a ...
1 Ιουν 2024 · In this review, we present a retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from June 2012 to August 2023 and provide insights based on the data presented in the article.
22 Ιουλ 2021 · Acella Pharmaceuticals, LLC issues voluntary nationwide recall of two lots of NP Thyroid®, thyroid tablets, USP due to sub potency. FDA, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-two-lots-np-thyroidr-thyroid-tablets (accessed 8 July 2021).
Ximelagatran (Exanta or Exarta, H 376/95) is an anticoagulant that has been investigated extensively as a replacement for warfarin [1] that would overcome the problematic dietary, drug interaction, and monitoring issues associated with warfarin therapy.
