Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
Reported: March 11, 2015 Initiated: February 23, 2015 #D-0398-2015
Product Description
Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
Reason for Recall
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.
Details
- Recalling Firm
- Sagent Pharmaceuticals Inc
- Units Affected
- 140,720 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Schaumburg, IL
Frequently Asked Questions
What product was recalled? ▼
Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05. Recalled by Sagent Pharmaceuticals Inc. Units affected: 140,720 vials.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 11, 2015. Severity: Moderate. Recall number: D-0398-2015.
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