ASHP News - Friday, September 12, 2014
Hospira on Thursday announced the recall of a single lot of heparin sodium injection in response to a confirmed report of a human hair contaminating the product. The recall affects 500-mL flexible plastic containers of heparin sodium in 0.9% sodium chloride injection, lot 41-046-JT, with a labeled expiration date of November 1, 2015. The lot was shipped nationwide from June through August of this year.
According to Hospira, the hair was found between the tube and the film at the round seal of the unused administrative port on one side of the container. The company is investigating the root cause of the problem.
For assistance with product returns, contact Stericycle at 855-201-4337 from 8:00 a.m. to 5:00 p.m. ET Monday through Friday.
Two other injectable products from Hospira were recalled earlier this month.
Lots 35-730-LL and 35-745-LL of buprenorphine hydrochloride injection in needleless syringes were recalled on September 9 because retained samples did not meet stability specifications or are expected to be out of specification before the product's February 1, 2015, expiration date.
Hospira stated that two adverse events have been reported for this lot, but it is not known whether the incidents were related to the amount of pseudobuprenorphine, a known impurity in buprenorphine pharmaceuticals.
The recalled lots were shipped from December 2013 through January 2014. Questions about product returns should be directed to Stericycle at 877-275-6842.
Hospira on September 4 recalled 0.5% bupivacaine hydrochloride injection, lot 37-268-DK, packaged in 30-mL single-dose vials, after confirming a report of iron particles embedded in the glass.
The vials have a January 1, 2016, expiration date and were shipped to customers from May to July 2014.
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