United States
Leiters Health is voluntarily recalling 33 lots of 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 products were distributed nationwide to hospitals for administration in the hospital. To date, Leiters Health has not received any reports of adverse events related to this recall.
Risk Statement: 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.
Fentanyl is an analgesic packaged in an IV bag under codes F3355 and F3342. Phenylephrine is used for perioperative hypotension, hypotension during anesthesia, and shock and is packaged in an IV bag under codes F3360 and F3352. Vancomycin is used for endocarditis and staphylococcal infections and is packaged in an IV bag under codes F3206 and F3208.
The affected products are:
- Item #F3355, FentaNYL 1000 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 100 mL IV bag, Lot # Expiration: 2331062 2/8/2024,
2331224 3/18/2024, 2331270 3/28/2024
- Item # F3342, FentaNYL 2500 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 250 mL IV bag, Lot # Expiration: 233098 1/31/2024, 2331058 2/18/2024, 2331150 3/10/2024, 2331231 3/24/2024, 2331289 3/30/2024.
- Item # F3360, Phenylephrine HCl 20 mg (80 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2330993 2/15/2024, 2331010 2/10/2024, 2331055 1/18/2024, 2331113 2/26/2024, 2331181 3/4/2024, 2331187 3/23/2024, 2331266 3/31/2024, 2331343 4/1/2024, 2331349 4/23/2024, 2331433 5/5/2024.
- Item # F3352, Phenylephrine HCl 40 mg (160 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2330939 1/30/2024, 2331032 2/3/2024, 2331112 3/19/2024, 2331190 3/26/2024, 2331429 4/28/2024.
- Item # F3206, Vancomycin HCl 1.25 g PF added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2331184 2/13/2024, 2331185 2/10/2024, 2331189 2/20/2024, 2331191 2/24/2024, 2331258 3/3/2024, 2331317 3/15/2024.
- Item # F3208, Vancomycin HCl 1.5 g PF added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2331140 2/8/2024, 2331188 2/15/2024, 2331261 3/5/2024, 2331287 3/14/2024
Leiters Health has notified its customers by a letter sent via mail, requiring signature upon receipt, and an email to all affected customers. Leiters Health is arranging for a credit for all recalled products. Customers that have product which is being recalled should cease using it and return it to Leiters Health.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Leiters Health
Brand name: Leiters, Compounding Health
Product recalled: Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags
Reason of the recall: Potential for superpotent drug
FDA Recall date: January 08, 2024
Source:
www.fda.gov
