Consumer Lawyers

FDA recalls injectable drugs: Phenylephrine HCl injection, USP, 1% 5 mL vial and cytarabine for injection, USP, 1 gram per vial, from Bedford Laboratories

In Uncategorized on February 28, 2012 at 2:50 am

The FDA has announced recalls of two injectable drugs: phenylephrine HCl injection, USP, 1% 5 mL vial, from American Regent, and cytarabine for injection, USP, 1 gram per vial, from Bedford Laboratories. On its Web site, the FDA posted press releases from both companies announcing the nationwide voluntary recalls.

Only one lot, Lot 0693, exp. date October 2012, was recalled of phenylephrine HCl injection, USP, 1% (10mg/mL), 5 mL vial NDC #0517-0405-25. The recall was prompted by potential safety concerns resulting from the identification of visible particles in some retained samples of the lot, according to the FDA. American Regent stated “it has not received any reports of adverse events related to this recall.”Potential adverse events after IV administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation, and granuloma formation, the FDA press release stated. Phenylephrine HCl injection is intended, among other uses, for the maintenance of adequate blood pressure during spinal and inhalation anesthesia, and treatment of vascular failure in shock, shock-like states, and drug-induced hypotension or hypersensitivity.

Three lots of the anticancer drug cytarabine for injection, USP, 1 gram per vial NDC #55390-133-01, were recalled: Lot 2066986, exp. date March 31, 2014; Lot 2111675, exp. date April 30, 2014; and Lot 2131148, exp. date May 31, 2014. Bedford Laboratories initiated the recall due to “a post-release investigation of the manufacturing area which determined a potential elevated risk of a lack of sterility assurance for these specific lots,” the FDA press release stated. Cytarabine is used in acute non-lymphocytic leukemia, acute lymphocytic leukemia, chronic myelocytic leukemia, and meningeal leukemia.

Both companies advise that healthcare facilities and providers should not use the recalled product lots and should immediately quarantine any product for return.

 

http://www.pharmacypracticenews.com/ViewArticle.aspx?d=Clinical&d_id=50&i=February+2012&i_id=810&a_id=20248

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