The company identified the particles as iron oxide and recalled lot 38-515-DK, Expiring on February 1, 2016, of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02). The lot was distributed from July 2014 to September 2014.
The recall affects human and veterinary indications.
Hospira said it is “working with its glass supplier and has initiated an investigation to determine the root cause and corrective and preventive actions.”
The company said if patients are injected with particulate, they risk “local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue, in particular in patients allergic or sensitive to iron oxide.
“In addition, therapy may be delayed if observation of particulate is not made until the point of care. This delay is likely to be of negligible clinical significance provided remediation is readily available.”
Hospira is notifying customers who received the damaged vials and arranging for them to be returned to Stericycle.
Earlier this month, the US Food and Drug Administration (FDA) issued Hospira with a warning letter for its manufacturing facility in Liscate, Italy. Inspectors found faults in sterility procedure, lack of investigation of failed batched, incomplete data, and other problems.
Allergan and Hospira recalls
Allergan has recalled antibiotic eye drops with the wrong label.
The company launched a pharmacy-level recall Exocin (ofloxacin) 3mg/ml eye drops which were mistakenly sent to the UK with Danish-language packaging.
Only one pack within batch number E75048, first distributed on March 3, 2015, is affected.
Ofloxacin is a synthetic version of the antibiotic fluoroquinolone.