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FDA MedWatch Intravia Containers by Baxter Recall

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FDA Medwatch Alert 10-20-14

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Etomidate Injection/Pfizer-Mylan: Recall - Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date

Friday, February 21, 2014

AUDIENCE: Pharmacy, Anesthesiology

ISSUE: Agila Specialties notified medical care organizations of a nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL – 10 mL and 20 mL (See the firm Press Release for a list of affected lot numbers). All of the products bear a Pfizer label. Product was distributed Nationwide to distributors, retailers, hospitals, pharmacies, and/or clinics.

The product was recalled 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.

BACKGROUND: Etomidate is a hypnotic drug indicated for the induction of general anesthesia. Etomidate 2 mg/mL is packaged in glass vials in 10 mL and 20 mL volumes.

RECOMMENDATION: Mylan notified its customers of the recall by letter on Feb.13, 2014. Distributors, retailers, hospitals, pharmacies, or clinics that have product which is being recalled should stop use and discontinue distribution.

Consumers with questions regarding this recall can contact Mylan Customer Service with questions at 800.848.0462 on Monday through Friday between 8 a.m. and 5 p.m. EST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Read the MedWatch safety alert, including a link to the Press Release, at:

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm386618.htm

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