Medicine recalls
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| The United States: Leiters Health issues voluntary nationwide recall of vancomycin IV bags, phenylephrine IV bags and fentanyl IV bags due to potential for superpotent drug |
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The US Food and Drug Administration (FDA) announces that Leiters Health is voluntarily recalling 33 lots of the following products to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug. The semi-automated IV bag filling equipment used to fill the recalled batches may not eject the IV bags properly when compressed air tanks become low or a leak was detected, causing the recalled IV bags to be dosed twice. The affected products are:
- Vancomycin HCl 1.25 g PF added to 0.9% Sodium Chloride 250 ml IV bag (lot number: 2331184, 2331185, 2331189, 2331191, 2331258, 2331317)
- Vancomycin HCl 1.5 g PF added to 0.9% Sodium Chloride 250 ml IV bag (lot number: 2331140, 2331188, 2331261, 2331287)
- Phenylephrine HCl 20 mg (80 mcg/ml) (from FDP) added to 0.9% Sodium Chloride 250 ml IV bag (lot number: 2330993, 2331010, 2331055, 2331113, 2331181, 2331187, 2331266, 2331343, 2331349, 2331433)
- Phenylephrine HCl 40 mg (160 mcg/ml) (from FDP) added to 0.9% Sodium Chloride 250 ml IV bag (lot number: 2330939, 2331032, 2331112, 2331190, 2331429)
- FentaNYL 1000 mcg (10 mcg/ml) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 100 ml IV bag (lot number: 2331062, 2331224, 2331270)
- FentaNYL 2500 mcg (10 mcg/ml) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 250 ml IV bag (lot number: 233098, 2331058, 2331150, 2331231, 2331289)
There is a reasonable probability that the use of the defective vancomycin and fentanyl IV bags will be associated with life-threatening adverse events. Administration of vancomycin at twice the infusion rate has been associated with low blood pressure, including shock and cardiac arrest, as well as wheezing, shortness of breath, hives, itchy skin and skin redness. Also, overdosing of vancomycin may be associated with acute kidney injury and ototoxicity. Administration of higher doses of fentanyl than intended can result in profound respiratory depression, which may not automatically be mitigated and treated, resulting in potential for delay in care and serious adverse outcomes from hypoxia, including permanent neurologic sequelae and death. In addition to respiratory depression, fentanyl can cause serious cardiac adverse events, such as hypotension, bradycardia, and vasodilation resulting in decrease in cardiac output and cardiac arrest. In addition, administration of a higher dose of phenylephrine than intended may cause higher-than-intended blood pressures in some patients.
To date, Leiters Health has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/leiters-health-issues-voluntary-nationwide-recall-vancomycin-iv-bags-phenylephrine-iv-bags-and
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Tuesday, Jan 9, 2024
Issued at HKT 14:00
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