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.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1418-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 17, 2011
- FDA report date
- Jul 25, 2012
- Quantity
- 478,569 Softgel Capsules (172,740 trade plus 305,829 samples).
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Meda Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1418-2012, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 61683
- Address
- 265 Davidson Ave Ste 300
- 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
- Postal code
- 08873-4120
- Report date
- Jul 25, 2012
- Product type
- Drugs
- Recall number
- D-1418-2012
- Classification
- Class II
- Recalling firm
- Meda Pharmaceuticals Inc.
- Product quantity
- 478,569 Softgel Capsules (172,740 trade plus 305,829 samples).
- Termination date
- Feb 8, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 17, 2011
- Initial firm notification
- Letter
- Center classification date
- Jul 13, 2012