FDA-Drug2012-07-25Class II

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

Meda Pharmaceuticals Inc.
Hazard

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.

Sold states
Nationwide
Affected count
478,569 Softgel Capsules (172,740 trade plus 305,829 samples).
Manufactured in
265 Davidson Ave Ste 300, Somerset, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1418-2012

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