Hospira, Inc., a subsidiary of pharmaceutical giant Pfizer Inc., is recalling specific lots of Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection Carpuject Units, as announced by the U.S. Food and Drug Administration (FDA).
The recall arises from the potential for incomplete crimp seals. The company has received one customer complaint regarding a leaking unit.
Buprenorphine Hydrochloride Injection is indicated for managing pain that necessitates an opioid analgesic, particularly when other treatments are inadequate. This injection is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous (IV) or intramuscular (IM) administration.
Labetalol Hydrochloride Injection is prescribed for controlling blood pressure in cases of severe hypertension.
The affected products were distributed nationwide to wholesalers and hospitals across the U.S. between September 2023 and April 2024.
If these compromised products are administered, there's a heightened risk of therapeutic failure and systemic infection, potentially necessitating additional medical intervention.
As of now, Pfizer has not received any reports of adverse events connected to these recalled lots.
The company has urged wholesalers and hospitals with existing inventories of any affected lots to discontinue use, halt distribution, and quarantine the products immediately.
In a similar event, Hospira recalled certain Sodium Bicarbonate and Lidocaine Hydrochloride Injections last October due to potential glass particulate contamination.
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