Recalls / Class II

Class IID-0399-2015

Product

Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10

Affected lot / code info

Lot Numbers: VATB012, VATB013, VATB014, Exp 11/15; VATB017, 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

140,850 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-0399-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.