Reported Mar 11, 2015 · Terminated
Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous…
Sagent Pharmaceuticals Inc.
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: Sagent Pharmaceuticals Inc · 1901 N Roselle Rd Ste 700 · Schaumburg, IL · 60195-3194
Is this the product you have?
- Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd
- forSagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
- Lot codes and dates
- Lot Numbers
VATA012Exp 11/15VATA015Exp 08/16
- Lot Numbers
- Amount recalled
- 140,720 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
This product could cause temporary or reversible health problems — stop using it.
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