FDAFDA · Food and drugs·Recall number D-1225-2014
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.
Published April 16, 2014 · Recall initiated: February 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Agila Specialties Private Ltd.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: a) 5000983, 5000986, Exp 08/14; 5001023, Exp 09/14; b) 5000927, 5000931, 5000936, 5000942, 06/14; 5001012, 5001040, Exp 09/14; 5001071, Exp 10/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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