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alert date:

May 21, 2024

Two Lots of Buprenorphine Hydrochloride Recalled Due to Incomplete Crimp Seals

Hospira, Inc., a Pfizer company, is voluntarily recalling two lots of Buprenorphine Hydrochloride Injection Carpuject Units 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. Buprenorphine HCl Injection is indicated for the management of pain requiring an opioid analgesic and for which alternate treatments are inadequate. The impacted lot numbers are HJ3965 and HJ8546. The products were distributed nationwide to wholesalers/hospitals in the United States from September 2023 through April 2024.

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