Massive Recall of IV Drugs

The FDA has announced a massive recall of several IV medications due to the possibility that they contain twice the listed dosage within the bag. Leiters Health is voluntarily cooperating with the recall after detecting an issue with the equipment used to fill the IV bags in 33 lots. Some of the drugs, particularly Fentanyl, may be fatal at the super potent doses. All medical facilities and pharmacies are urged to immediately inspect their inventory and remove all stock affected by the recall.

As of the writing of this notice, the FDA has not received any reports of adverse events related to the improperly dosed batch of medications.

SUMMARY

Date of Recall:

Announced: January 5, 2024

Public Notification: January 8, 2024

Name(s) of Drug:

Numerous Drugs Affected

Company Name:

Leiters HEalth

Brand Name:

Leiters, Compounding Health

Drug Indication:

Several indications

Product Description

Health systems nationwide received distributions of medication. The medications were in prepared IV bags and clearly labeled with the drug name and intended dosage. All three drugs were contained within a bag of 0.9% Sodium Chloride in either a 100mL or 250mL bag.

Reason for Recall

Inspectors noted a defect in the machine responsible for distributing the drug into the solution. The defective machine may have resulted in up to double the dose of the medication being inserted into the bag. Without testing the solution, there is no way to know if it is properly dosed. Therefore, the manufacturer is voluntarily recalling the affected lots.

Impacts

These drugs are extremely dangerous when not dosed properly, and each poses a threat in its own way. For instance, patients who receive a higher-than-intended dose of Vancomycin may experience life-threatening adverse events such as:

• Low blood pressure
• Shock
• Cardiac arrest
• Wheezing
• Shortness of breath
• Hives
• Itchy skin
• Acute kidney injury
• Ototoxicity (hearing damage)
• Death

Similarly, patients who receive a higher-than-intended dose of Fentanyl may experience life-threatening adverse events, including:

• Respiratory depression (loss of breathing function)
• Brain damage
• Low blood pressure
• Low heart rate
• Cardiac arrest
• Death

Patients who receive a higher-than-intended dose of Phenylephrine may experience life-threatening adverse events, including:

• High blood pressure

Lot Information

All pharmacies and medical institutions are urged to inventory their stock for the presence of the recalled drugs. Compare existing stock with the product information in the chart below. Remove any stock that matches the drug name, strength, item number, lot number, and expiration date from circulation. Follow the recall procedures listed below.

FDA.gov

Have you found that the medication in your stock is part of the recall? Here’s what you should do:

Health Systems

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Leiters Health at 1-800-292-6772 or recall@leiters.com for assistance.
3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Leiters Health at 1-800-292-6772 or recall@leiters.com for assistance.
3. If you have additional questions, contact Pfizer Medical Information at 1 (800) 438-1985, option 3. They are available Monday-Friday from 9:00 a.m. to 5:00 p.m. ET. You may also contact them online at www.pfizermedinfo.com.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug and alcohol, and hospice and palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!