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Zemuron |
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Zemuron,
trademark for a nondepolarizing neuromuscular blocking agent (rocuronium bromide). Want to thank TFD for its existence? Tell a friend about us, add a link to this page, add the site to iGoogle, or visit the webmaster's page for free fun content. |
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The inspection revealed that the QC unit failed to prevent the release of 10 lots of Zemuron Injection (rocuronium bromide) that were adulterated with metal fragments from its manufacturing equipment; failed to conduct a thorough analysis of the particulate matter leading to the rejection of two other lots; and, failed to assure that equipment used during manufacturing would not alter the safety, identity, strength, quality or purity of the drug product. FDA cited Organon for two instances in which the firm failed to file reports of adverse drug events in connection with Pavulon (pancuronium bromide) within 15 days and three instances in which adverse events connected to Zemuron (rocuronium bromide) did not make it to FDA within 15 days. The agency hammered away at the firm's practices regarding one lot of Zemuron (rocuronium bromide), which FDA insisted was tainted with Bacillus circulans. |
Zemuron |
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