Drug product
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
D-396-2014
Product summary
- Event
- Event 66955
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,512 bottles
- Official record key
drug-enforcement:D-396-2014
Official wording
Reason: Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Code information: Lot#: 32900349B, Exp: 12/2014
Distribution pattern: Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.