Drug product
Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.
D-238-2013
Product summary
- Event
- Event 64733
- Status
- Terminated
- Classification
- Class III
- Quantity
- 117,546 bottles
- Official record key
drug-enforcement:D-238-2013
Official wording
Reason: Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Code information: Lot #: C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15.
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Unknown
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.