FDA MedWatch – Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units by Hospira

TOPIC: Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units by Hospira: Recall – Due to the Potential for Incomplete Crimp Seals 

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: Hospira is recalling lots of Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units due to the potential for incomplete crimp seals, because one customer complaint has been received for one leaking unit.

In the event that impacted products are administered to a patient, there is a potential for an increased risk of lack of therapeutic effect and systemic infection that may result in the need for additional medical treatment.

The products were distributed nationwide to wholesalers/hospitals in the United States from September 2023 through April 2024.

To date, Pfizer has not received reports of any relevant adverse events associated with this issue for these lots.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND:

• Buprenorphine HCl Injection is indicated for the management of pain requiring an opioid analgesic and for which alternate treatments are inadequate.

• Labetalol HCl Injection is indicated for control of blood pressure in severe hypertension.

RECOMMENDATIONS: 

• Wholesalers and hospitals with an existing inventory of any of the lots which are being recalled should discontinue use, stop distribution, and quarantine the product immediately.

• If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product.

• Hospitals should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Sedgwick at 800-805-3093.

• Healthcare Professionals with questions regarding this recall can contact Pfizer. 

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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