Recalls / Class II
Class IID-0398-2015
Product
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
- Affected lot / code info
- Lot Numbers: VATA012, Exp 11/15; VATA015, Exp 08/16
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.
Recalling firm
- Firm
- Sagent Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 700, N/A, Schaumburg, Illinois 60195-3194
Distribution
- Quantity
- 140,720 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-02-23
- FDA classified
- 2015-03-03
- Posted by FDA
- 2015-03-11
- Terminated
- 2016-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0398-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.