Reported Jul 25, 2012 · Terminated

Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For:…

Meda Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Meda Pharmaceuticals Inc. · 265 Davidson Ave Ste 300 · Somerset, NJ · 08873-4120

Is this the product you have?

  • Prefera OB One Gel Capsules, 30 softgels, Rx Only
  • Manufactured byIVC industries, Inc. Irving ton, NJ 07111
  • For
    • Alaven Pharmaceutical LLC Marietta
    • GA 30062
    • NDC 68220-086-30
Lot codes and dates

10 of 10 products

Products covered by this recall
#Product as published
1Lot 249814 Samples
2Lot 249816 samples
3Lot 260393 exp 4/30/20012
4Lot 255345 exp 11/30/2011
5Lot 000001 exp 8/31/2012
6Lot 261827 exp 5/31/2012
7Lot 50004 exp 11/30/2012
8Lot 50005 exp 11/30/2012
9Lot 500007 exp 12/31/2012
10Lot 000002 exp 9/30/20012
Amount recalled
478,569 Softgel Capsules (172,740 trade plus 305,829 samples).

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 8, 2017 · Data as of Sep 19, 5:01 PM UTC

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