October 2011 FDA Recall Drug by Meda Pharmaceuticals Inc.
D-1418-2012 - Labeling

This Class II drug recall was voluntarily initiated by Meda Pharmaceuticals Inc. on October 17, 2011 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1418-2012

Reason for Recall
Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.
Initiated
10-17-2011
Reported
07-25-2012
Quantity
478,569 Softgel Capsules (172,740 trade plus 305,829 samples).

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61683
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.
Meda 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2017
Product Description About Product Description
Full technical description of the product.
Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30

Batch or Lot Expiration Information

Lot# Lot 249814 Samples Lot 249816 samples Lot 260393 exp 4/30/20012 Lot 255345 exp 11/30/2011 Lot 000001 exp 8/31/2012 Lot 261827 exp 5/31/2012 Lot 50004 exp 11/30/2012 Lot 50005 exp 11/30/2012 Lot 500007 exp 12/31/2012 Lot 000002 exp 9/30/20012