Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving t...
FDA Recall #D-1418-2012 — Class II — October 17, 2011
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
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.
Recalling Firm
Meda Pharmaceuticals Inc. — Somerset, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
478,569 Softgel Capsules (172,740 trade plus 305,829 samples).
Distribution
Nationwide
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated