FDA Recall of Injectable Medication - MedWaste Management FDA Recall of Injectable Medication - MedWaste Management

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FDA Recall Injectable Medications

FDA Recall of Injectable Medication

The FDA announced a recall of two injectable medications this week. The medications, typically administered by healthcare professionals, have the potential to cause systemic infection due to a report that one package had been found with an incomplete seal.

Healthcare providers must check their stock and remove any medications included in this recall. Patients who receive the injections should do their due diligence by requesting that healthcare providers compare individual vial information to listed lot numbers to confirm safety.

As of the writing of this notice, the FDA has not announced any adverse events related to the contamination.

SUMMARY

 

Date of Recall:

Announced: May 21, 2024

Public Notification: May 22, 2024

 

Name(s) of Drug:

Buprenorphine Hydrochloride Injection Carpuject Units

Labetalol Hydrochloride Injection, USP Carpuject Units

 

Company Name:

Hospira Inc.

 

Drug Indication:

See Below

 

FDA Recall Labetalol Hydrochloride Injection
FDA Recall Buprenorphine Hydrochloride Injection

Product Description

The medications included in this recall are distributed within individual health systems. They are available by prescription only and are administered by healthcare professionals.

Each is packaged in individual clear glass vials with green caps. The vials are clearly labeled with the drug name, dosage, NDC number, lot number, and expiration date.

Buprenorphine Hydrochloride is most commonly used to treat pain in patients who are unable to take first-line opioid pain-relieving medications.

Labetalol Hydrochloride is used to treat hypertension, also known as high blood pressure.

Reason for Recall

A customer reported that a proper seal was not maintained on their vial. This could lead to decreased medication efficacy and an increased chance of systemic infection. Out of an abundance of caution, the manufacturer is recalling these lots as they continue their investigation.

Impacts

Consumers who receive an injection of improperly sealed medication may not receive the full benefit of the medication. In this case, that could mean prolonged pain or increased blood pressure leading to stroke. Additionally, unsealed vials can lead to life-threatening systemic infections by bacteria or viruses that may have entered the liquid.

Recall Lot Information

Wholesalers and healthcare providers must check their entire stock of the medications listed. Carefully compare the NDC and lot numbers, as well as the expiration date of each vial to the chart below. If you find any matches, read further for instructions on taking part in the recall.

ProductNDCLot NumberExpiration DateConcentrationConfiguration/ Count
Buprenorphine Hydrochloride Injection – CIII
CarpujectTM Single-dose Cartridge/Tube Unit with Luer Lock
Carton 0409-2012-32
Cartridge 0409-2012-03
HJ39652024/090.3 mg base/mL10 cartridge
units/carton
HJ85462024/100.3 mg base/mL10 cartridge units/carton
Labetalol Hydrochloride Injection, USP
CarpujectTM Single-dose Cartridge Unit with Luer Lock
Bundle 0409-2339-34
Carton/Cartridge 0409-2339-24
HJ75662025/0520 mg/4 mL
(5 mg/mL)
10 carton/ cartridge
units/bundle
HN87472025/0920 mg/4 mL
(5 mg/mL)
10 carton/ cartridge
units/bundle
HN87492025/0920 mg/4 mL
(5 mg/mL)
10 carton/ cartridge
units/bundle

FDA.gov

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

Consumers

If you find that your lot of medication is part of this recall, do the following:

  1. Patients must refuse the administration of a medication that is listed on the recall.
  2. Patients, ask your doctor to replace the recalled injection with another that is not recalled. You may allow the medication to be injected as long as the lot number, NDC number, and expiration date do not match the chart.
  3. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.

Healthcare Systems

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Sedgwick at 1-800-805-3093. They are available from 8 a.m. to 5 p.m. EST, Monday through Friday.
  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 Sedgwick at 1-800-805-3093. They are available from 8 a.m. to 5 p.m. EST, Monday through Friday. Wholesalers must notify Sedgwick of any recalled batches that they have already shipped to medical facilities.
  3. Notify affected medical facilities of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal in the healthcare industry and the general public. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

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Tammy McKinney, Nurse Writer Healthcare Content Creator Byline Image

Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & 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!

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