US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 14, 2014 (13 years ago)

etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Particulate Matter: Potential for small black particles 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.

What was recalled

etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY 10017.

Recalling firm
Agila Specialties Private Ltd.
NDC code
0069-0006-02
Origin
N/A, India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1225-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Etomidate recalls

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Class II · Moderate risk Terminated

ETOMIDATE 0.2% (2MG/ML) INJECTABLE 20 ML (1 PRODUCT)

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1517-2012