(RTTNews) - Hospira, Inc., affiliated to dug major Pfizer Inc., is recalling select lots of Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection Carpuject Units, according to the U.S. Food and Drug Administration.
The recall was initiated due to the potential for incomplete crimp seals. The company has received one customer complaint for one leaking unit.
The Buprenorphine HCl Injection is indicated for the management of pain requiring an opioid analgesic and for which alternate treatments are inadequate. The injection is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous or IV or intramuscular or IM administration.
Labetalol HCl Injection is indicated for control of blood pressure in severe hypertension.
The impacted products were distributed nationwide to wholesalers/hospitals in the U.S. from September 2023 through April 2024.
If 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.
So far, Pfizer has not received reports of any relevant adverse events associated with the issue for the recalled lots.
The company urged wholesalers and hospitals with an existing inventory of any of the recalled lots to discontinue use, stop distribution, and quarantine the product immediately.
Hospira in October last year had called back certain Sodium Bicarbonate and Lidocaine HCl Injections citing the potential for presence of glass particulate matter.
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