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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description 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
Recall Number D-1418-2012
Classification Class II
Code Info 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
Product Distributed Qty 478,569 Softgel Capsules (172,740 trade plus 305,829 samples).
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.

Event Detail

Event Id 61683
Product Type Drugs
Status Ongoing
Recalling Firm Meda Pharmaceuticals Inc.
City Somerset
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-10-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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