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Safety Report: Hospira Buprenorphine Hydrochloride Injection and Labetalol Hydrochloride Injection - recalled due to Packaging Defect, USA

3 weeks ago •source fda.gov

Recall notice

Hospira Buprenorphine Hydrochloride Injection and Labetalol Hydrochloride Injection - recalled due to Packaging Defect photo #1

United States

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

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.

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 recalled products, NDC, Lot Number, Expiration Date, and Configuration details for the impacted products are Attached.

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.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Hospira Inc.
Brand name: Hospira
Product recalled: Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units
Reason of the recall: Device & Drug Safety – Potential Packaging Defect
FDA Recall date: May 22, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-buprenorphine-hydrochloride-injection-carpujecttm

#drugs #recall #pfizer #us

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