FDA warns – Buprenorphine Hydrochloride Injection Carpuject™ Units and Labetalol Hydrochloride Injection, USP Carpuject™ Units recalled by Hospira due to potential packaging issue

According to the FDA, Hospira Inc., a Pfizer company based in New York, New York, has voluntarily recalled certain lots of its Buprenorphine Hydrochloride Injection Carpuject™ Units and its Labetalol Hydrochloride Injection, USP Carpuject™ Units.

The user-level recall was announced by the company on May 21, 2024, after officials received a customer complaint about a leaking unit, which then pointed to the potential for incomplete crimp seals in certain lots.

Indicated for pain management that requires an opioid analgesic, Buprenorphine HCI Injection is used in cases where other treatments are not adequate. A clear and sterile injectable, it is an agonist-antagonist analgesic intended to be administered intravenously (IV) or intramuscularly (IM).

Patients with severe hypertension use Labetalol HCI Injection to control blood pressure.

While Pfizer says it has not been notified of any adverse events in connection with the products in the selected lots to date, patients and healthcare providers should be aware that administering affected products may not resulted in the intended therapeutic effect. Patients could also suffer a systemic infection that requires additional medical intervention.

Distributed to wholesalers and hospitals across the country between September 2023 and April 2024, impacted products with the following NDC, Lot Number, Expiration Date, and Configuration details are covered by the recall:

  • Buprenorphine Hydrochloride Injection – CIIICarpuject™ Single-dose Cartridge/Tube Unit with Luer Lock
    • NDC: Carton 0409-2012-32, Cartridge 0409-2012-03
    • Lot Numbers: HJ3965, HJ8546
    • Expiration Dates: 2024/09, 2024/10
    • Concentrations: 0.3 mg base/mL,0.3 mg base/mL
    • Configurations/Counts: 10 cartridge units/carton; 10 cartridge units/carton
  • Labetalol Hydrochloride Injection, USP Carpuject™ Single-dose Cartridge Unit with Luer Lock
    • NDC: Bundle 0409-2339-34Carton/Cartridge 0409-2339-24
    • Lot Numbers: HJ7566, HN8747, HN8749
    • Expiration Dates: 2025/05, 2025/09, 2025/09
    • Concentrations: 20 mg/4 mL (5 mg/mL)
    • Configurations/Counts: 10 carton/ cartridge units/bundle

While Pfizer has since sent letters to its direct consignees to alert them of the recall and to establish a return program for all recalled product, any existing inventory that remains in the possession of wholesalers and hospitals should be discontinued. All further distribution of the product should be halted, and the items should be immediately quarantined. Customers are urged to notify accounts and other locations which may have received a sub-distribution of the affected products, and all relevant healthcare professionals should be alerted.

Further questions may be directed to Sedgwick by calling 800-805-3093. Representatives are available Monday through Friday, from 8:00 a.m. to 5:00 p.m. Eastern Time.

As the FDA continues to oversee this recall, those who may have experienced an adverse reaction and/or other quality issues while using the product are encouraged to report to the agency’s MedWatch Adverse Event Reporting program.


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