NEW YORK CITY (dpa-AFX) - 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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