D-1418-2012 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 25, 2012
- Initiation Date
- October 17, 2011
- Termination Date
- February 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 478,569 Softgel Capsules (172,740 trade plus 305,829 samples).
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.
Distribution Pattern
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