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

FDA recall notice · announced July 25, 2012 · Meda Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide
Lot/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
Quantity: 478,569 Softgel Capsules (172,740 trade plus 305,829 samples).
Status: Terminated
Products in this recall event:
- 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 (D-1418-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.