Why it was recalled
Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.
Product description
Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2.
Lot numbers, UPCs & expiration codes
Lot #: 505024006, 505024007, Exp 03/15; 505024008; 505024009, Exp 06/15; 505024010, Exp 08/15; 505024011, Exp 09/15; and 505024012, Exp 10/15
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-1544-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 17, 2014
- FDA report date
- Aug 27, 2014
- Quantity
- 142,732 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Trigen Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1544-2014, exactly as published.
Show all FDA fields
- City
- Tampa
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 68685
- Address
- 2631 Causeway Center Dr
- Code information
- Lot #: 505024006, 505024007, Exp 03/15; 505024008; 505024009, Exp 06/15; 505024010, Exp 08/15; 505024011, Exp 09/15; and 505024012, Exp 10/15
- Postal code
- 33619-6102
- Report date
- Aug 27, 2014
- Product type
- Drugs
- Recall number
- D-1544-2014
- Classification
- Class III
- Recalling firm
- Trigen Laboratories, Inc.
- Product quantity
- 142,732 bottles
- Termination date
- Jul 26, 2017
- Reason for recall
- Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 17, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 19, 2014