July 2014 FDA Recall Drug by Ben Venue Laboratories Inc
D-1543-2014 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Ben Venue Laboratories Inc on July 31, 2014 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1543-2014

Reason for Recall
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Initiated
07-31-2014
Reported
08-27-2014
Quantity
7172 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68800
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.
Ben Venue Laboratories 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2014
Product Description About Product Description
Full technical description of the product.
CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01

Batch or Lot Expiration Information

Lot# 0161-13-2167551; Exp. 07/14
Lot# 0161-13-2176919; Exp. 08/14