Hospira Recalls Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units

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Hospira, a Pfizer company, announced on May 21, 2024 that it was voluntarily recalling the lots listed in the table below of Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units because of incomplete crimp seals. The company also received a customer complaint of a leaking unit.

The recalled lots were distributed nationwide to wholesalers/hospitals in the United States from September 2023 through April 2024. The National Drug Code (NDC), lot number, expiration date, and configuration details for the recalled lots are as follows:

• Buprenorphine Hydrochloride Injection–CIII, Carpuject Single-dose Cartridge/Tube Unit with Luer Lock. NDC: Carton 0409-2012-32, Cartridge 0409-2012-03; lot number HJ3965, expiration date 2024/09; lot number HJ8546, expiration date 2024/10. Both have a concentration of 0.3 mg base/mL and are 10 cartridge units/carton.
• Labetalol Hydrochloride Injection, USP Carpuject Single-dose Cartridge Unit with Luer Lock. NDC: Bundle 0409-2339-34, Carton/Cartridge 0409-2339-24; lot number HJ7566, expiration date 2025/05; lot number HN8747, expiration 2025/09; HN8749 expiration date 2025/09. Both have a concentration of 20 mg/4 mL (5 mg/mL) and are 10 carton/ cartridge units/bundle.

While Pfizer has not received any related reports of adverse events, if an impacted product is administered, there is an increased risk for lack of efficacy and systemic infection that might require additional treatment, according to the company. Adverse events may be reported to FDA through the agency’s MedWatch program.

“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,” the company stated in a press release (1).

Buprenorphine HCl Injection, a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous or intramuscular administration, is used to manage pain for which alternate treatments are inadequate. Labetalol HCl Injection is a treatment for controlling blood pressure in severe hypertension.

In December 2023, the company had another voluntary recall. That recall was of lots of 4.2% Sodium Bicarbonate Injection, USP ABBOJECT Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield ABBOJECT Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP Lifeshield ABBOJECT Glass Syringe, 1 mg/10 mL because of the presence of glass particulate matter found during product inspection (2).

“Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies,” the company stated in the release (2).

References

1. Hospira. Hospira Inc. Issues a Voluntary Nationwide Recall for Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units Due to the Potential for Incomplete Crimp Seals. FDA.gov. Press Release. May 21, 2024.
2. Hospira. Hospira, Inc. Issues A Voluntary Nationwide Recall For 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection Due to the Potential Presence of Glass Particulate Matter. Press Release. FDA.gov. Dec. 21, 2023.