 "Agila starts voluntary recall of anesthetic injection in US")
Mylan had recently acquired Agila Specialties from Bangalore-based Strides Arcolab for a hefty $1.6 billion.
Around the time of the transaction, the United States’ Food and Drug Administration had issued a warning letter to a unit of Agila, which is still being rectified.
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Ranbaxy, which is now part of Daiichi Sankyo of Japan, has been hit severely by a series of tightening measures by United States’ Food and Drug Administration.
A statement on the United States’ FDA website states that the 10 lots of Etomidate injection were manufactured by Agila Specialties Polska in Warsaw, Poland.
All of the products bear a Pfizer label.
Agila Specialties initiated the recall on February 13, 2014, due to the potential for small black particles, identified as paper shipper labels, to be present in individual vials; the potential for missing lot number and/or expiry date on the outer carton, and the potential for illegible/missing lot number and expiry on individual vials.
“Intravenous administration of particles may lead to impairment of microcirculation, phlebitis, infection, embolism and subsequent infarction,” according to the statement.
“Mylan and Pfizer have not received any reports of adverse events relating to the recalled product to date,” the statement noted.
Etomidate is a hypnotic drug without analgesic activity. It is indicated by intravenous injection for the induction of general anesthesia.
Etomidate is also indicated for the supplementation of subpotent anesthetic agents. Etomidate 2 mg/ml is packaged in glass vials in 10 ml and 20 ml volumes.
The product was distributed across the US to distributors, retailers, hospitals, pharmacies, and/or clinics.