Leiters Health recalls 33 Lots of 6 Products


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Leiters Health Recalled Product Labels


Englewood, Colorado, Leiters Health is voluntarily recalling 33 lots of products listed below 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.

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 products were distributed nationwide to hospitals for administration in the hospital. 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.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Customers will receive return shipping labels for phenylephrine and vancomycin returns via email from Leiters Health to return their products to Leiters Health at 13796 Compark Blvd., Englewood, CO 80112. Customers will receive return shipping labels, along with a DEA Form 222, for fentanyl returns via mail from Leiters Health to return their products to Leiters Health at 13796 Compark Blvd., Englewood, CO 80112.

Source: FDA

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Consumer Contact: -

Consumers with questions regarding this recall can contact Leiters Health by phone at 1-800-292-6772 or e-mail at recall@leiters.com Monday through Friday between 8:00 AM MST and 5:30 PM MST.

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Item #

Product Description

Lot #

Expiration

F3355 FentaNYL 1000 mcg (10 mcg/mL) (as FentaNYL Citrate) PF
(from API) added to 0.9% Sodium Chloride 100 mL IV bag
2331062 2/8/2024
2331224 3/18/2024
2331270 3/28/2024
F3342 FentaNYL 2500 mcg (10 mcg/mL) (as FentaNYL Citrate) PF
(from API) added to 0.9% Sodium Chloride 250 mL IV bag
233098 1/31/2024
2331058 2/18/2024
2331150 3/10/2024
2331231 3/24/2024
2331289 3/30/2024
F3360 Phenylephrine HCl 20 mg (80 mcg/mL) (from FDP) added to
0.9% Sodium Chloride 250 mL IV Bag
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
F3352 Phenylephrine HCl 40 mg (160 mcg/mL) (from FDP) added
to 0.9% Sodium Chloride 250 mL IV Bag
2330939 1/30/2024
2331032 2/3/2024
2331112 3/19/2024
2331190 3/26/2024
2331429 4/28/2024
F3206 Vancomycin HCl 1.25 g PF added to 0.9% Sodium Chloride
250 mL IV Bag
2331184 2/13/2024
2331185 2/10/2024
2331189 2/20/2024
2331191 2/24/2024
2331258 3/3/2024
2331317 3/15/2024
F3208 Vancomycin HCl 1.5 g PF added to 0.9% Sodium Chloride
250 mL IV Bag
2331140 2/8/2024
2331188 2/15/2024
2331261 3/5/2024
2331287 3/14/2024

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.


Report a Problem With This Product

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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You Are Leaving Us

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