Hospira Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol recall: Device & Drug Safety – Potential Packaging Defect

What the company announced

FOR IMMEDIATE RELEASE – 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: Buprenorphine Hydrochloride Injection – CIII CarpujectTM Single-dose Cartridge/Tube Unit with Luer Lock · NDC: Carton 0409-2012-32 Cartridge 0409-2012-03 · Lot Number: HJ3965 · Expiration Date: 2024/09 · Concentration: 0.3 mg base/mL · Configuration/ Count: 10 cartridge units/carton
• Product: HJ8546 · NDC: 2024/10 · Lot Number: 0.3 mg base/mL · Expiration Date: 10 cartridge units/carton
• Product: Labetalol Hydrochloride Injection, USP CarpujectTM Single-dose Cartridge Unit with Luer Lock · NDC: Bundle 0409-2339-34 Carton/Cartridge 0409-2339-24 · Lot Number: HJ7566 · Expiration Date: 2025/05 · Concentration: 20 mg/4 mL (5 mg/mL) · Configuration/ Count: 10 carton/ cartridge units/bundle
• Product: HN8747 · NDC: 2025/09 · Lot Number: 20 mg/4 mL (5 mg/mL) · Expiration Date: 10 carton/ cartridge units/bundle
• Product: HN8749 · NDC: 2025/09 · Lot Number: 20 mg/4 mL (5 mg/mL) · Expiration Date: 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: Pfizer Medical Information · Contact Information: 800-438-1985, option 3 (Mon.-Fri. 9am – 5pm ET) www.pfizermedinfo.com · Area of Support: For medical questions regarding the product
• Contact Center: Pfizer Drug Safety · Contact Information: 800-438-1985, option 1 (24 hours a day; 7 days a week) · Area of Support: 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.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

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Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.