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Hospira Issues Recall for Particles Found in Vials

Nick Naughton3 years ago

Hospira, Inc. recently initiated a voluntary nationwide recall for one lot of 0.25% Bupivacaine HCl Injection, USP (2.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1159-02). The recall was expanded in August to also include a lot of 0.75% Bupivacaine HCl Injection, USP (7.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1165-02).

About the Bupivacaine HCL Injection Lots Recall

According to the U.S Food and Drug Administration (FDA), the recall was made in response to reports of particulate matter floating or embedded in the drugs glass vials. The FDA recommends that anyone with an existing inventory should immediately stop using the product and return the product to Stericycle.

Description of Recalled Bupivacaine HCL Injection Lots

  • The products are packaged 25 units per carton/50 units per case in glass teartop vials.
  • The particulate was identified as stainless steel ranging in size from 542 microns to 1700 microns in lot 18-136-DK (0.25% bupivacaine) and as iron oxide with an average size of 2000 microns in lot 23-338-DK (0.75% bupivacaine).
  • According to the FDA release, lot 18-136-DK was distributed August 2012 through September 2012 while lot 23-338-DK was distributed between January 2013 and May 2013 to wholesalers/distributors, hospitals and pharmacies.
  • According to the National Library of Medicine, presence of foreign particulates may potentially cause thrombophlebitis, bacteremia, sepsis, and/or endocarditis and death may result.
  • Signs and symptoms could include redness, pain, swelling at the site, fever, shortness of breath, tachycardia, nausea and vomiting.
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