June 2013 FDA Recall Drug by Sagent Pharmaceuticals Inc
D-605-2013 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Sagent Pharmaceuticals Inc on June 7, 2013 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-605-2013

Reason for Recall
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Initiated
06-07-2013
Reported
06-26-2013
Quantity
831,950 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65339
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sagent Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2015
Product Description About Product Description
Full technical description of the product.
VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.

Batch or Lot Expiration Information

Lot# s: 11F23921A, 11G24001A, 11G24251A, 11G24471A, 11G24701A, 11G25051A, 11G25471A, 11G24341A, Exp 07/13; 11I30521A, 11I31651A, 11I31661A, 11I30481A, 11I30721A, 11I30731A, Exp 09/13; 11I32581A, 11K34241A, 11K34471A, 11K35861A, 11K36761A, 11K37451A, 11K37471A, 11K38171A, Exp 10/13; 11L40161A, 11L40201A, 11L40891A, 11L40781A, 11L40851A, 11L40921A, 11L42961A, Exp 11/13; 11M44271A, 11M44371A, 11M44381A, 11M45041A, 11M45421A, 11M45641A, Exp 12/13; 12A02161A, Exp 01/14; 12B04871A, 12B04921A, 12B06501A, 12B06741A, Exp 02/14; 12C09031A, 12C09041A, 12C09301A, 12C09461A, 12C09471A, 12C11641A, Exp 03/14; 12D12401A, 12D12761A, 12D12861A, 12D13061A, 12D13351A, 12D13361A, 12D13401A, Exp 04/14; 12E15981A, Exp 05/14