FDANews

Hospira, Daiichi Sankyo Recall Products Due to Stability Failures DUPLICATE

Hospira is voluntarily recalling more than 24,000 syringes of the injectable Amidate because out-of-specification results for degraded product were confirmed during stability testing.

According to an Oct. 28 FDA enforcement report, Hospira initiated the nationwide recall of one lot of the etomidate injection 40 mg/20 ml product on Sept. 29. The FDA classified the recall Class 3.

The product had an expiration date of Oct. 1, 2015, so any remaining product should not be used. It was distributed from December 2013 through September 2014, said Pfizer spokeswoman Kim Bencker. Pfizer’s acquisition of Hospira closed in early September (DID, Aug. 25). 

In another announcement Friday, Japanese drugmaker Daiichi Sankyo said its vaccine subsidiary Kitasato Daiichi Sankyo is voluntarily recalling two vaccines — six lots of a combined vaccine for attenuated measles and rubella and one lot of a stand-alone vaccine for the attenuated measles virus.

Both freeze-dried, live vaccines are names Kitasatodaiichisankyo, and they are being recalled because stability monitoring revealed that potency of the measles virus could fall below the approved standard for product shelf-life.

Daiichi Sankyo said that there are no reports of efficacy and safety concerns, and it is checking other non-recalled products to confirm their potency meets standards. — Kellen Owings