Reported Apr 16, 2014 · Terminated
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…
Agila Specialties Private Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Agila Specialties Private Ltd. · Sterile Product Division, Opp IIM, · Bangalore, Karnataka, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: a) 50009835000986Exp 08/145001023Exp 09/14b) 500092750009315000936500094206/1450010125001040Exp 09/145001071Exp 10/14
- Amount recalled
- 7919 cartons
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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