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FDA Alert: Hospira Inc. Issues Voluntary Recall for Buprenorphine HCl Injection Carpuject Units and Labetalol HCl Injection Carpuject Units Due to Potential for Incomplete Crimp Seals

May 21, 2024

Audience: Healthcare Provider, Pharmacy, Consumer

May 21, 2024 – NEW YORK, NY., Hospira, Inc., a Pfizer company (“Pfizer”), is voluntarily recalling the lots listed in the table below of Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units to the User level. The recall was initiated due to the potential for incomplete crimp seals; 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. To date, Pfizer has not received reports of any relevant adverse events associated with this issue for these lots.

Buprenorphine HCl Injection is indicated for the management of pain requiring an opioid analgesic and for which alternate treatments are inadequate. Buprenorphine HCl Injection is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous (IV) or intramuscular (IM) administration.

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

The NDC, Lot Number, Expiration Date, and Configuration details for the impacted products are indicated below. The products were distributed nationwide to wholesalers/hospitals in the United States from September 2023 through April 2024.

Product NDC Lot Number Expiration Date Concentration Configuration/ Count
Buprenorphine Hydrochloride Injection – CIII
CarpujectTM Single-dose Cartridge/Tube Unit with Luer Lock
Carton 0409-2012-32
Cartridge 0409-2012-03
HJ3965 2024/09 0.3 mg base/mL 10 cartridge
units/carton
HJ8546 2024/10 0.3 mg base/mL 10 cartridge units/carton
Labetalol Hydrochloride Injection, USP
CarpujectTM Single-dose Cartridge Unit with Luer Lock
Bundle 0409-2339-34
Carton/Cartridge 0409-2339-24
HJ7566 2025/05 20 mg/4 mL
(5 mg/mL)
10 carton/ cartridge
units/bundle
HN8747 2025/09 20 mg/4 mL
(5 mg/mL)
10 carton/ cartridge
units/bundle
HN8749 2025/09 20 mg/4 mL
(5 mg/mL)
10 carton/ cartridge
units/bundle

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for the return of any recalled product.

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 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the information below.

Contact
Center
Contact Information Area of Support
Pfizer Medical
Information
800-438-1985, option 3
(Mon.-Fri. 9am – 5pm ET)
www.pfizermedinfo.com
For medical questions
regarding the product
Pfizer Drug
Safety
800-438-1985, option 1
(24 hours a day; 7 days
a week)
To report adverse events
and product complaints

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.

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

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