D-1544-2014 Class III Terminated
FDA drug recall D-1544-2014 was initiated by Trigen Laboratories, Inc. on April 17, 2014 and is designated Class III. 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 Vitam… The recall status is terminated (terminated July 26, 2017). Affected quantity: 142,732 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 27, 2014
- Initiation Date
- April 17, 2014
- Termination Date
- July 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 142,732 bottles
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.
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.
Distribution Pattern
Nationwide
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