Drug product
Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.
D-1427-2012
Product summary
- Firm
- Stat Rx USA
- Event
- Event 62639
- Status
- Terminated
- Classification
- Class III
- Quantity
- 51 Bottles
- Official record key
drug-enforcement:D-1427-2012
Official wording
Reason: Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Code information: Lot #: 28JN1272, Exp 02/15
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up