Buprenorphine Hydrochloride Injection Carpuject
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.
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.
Source: FDA
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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.
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Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
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