D-1427-2012 Class III Terminated
FDA drug recall D-1427-2012 was initiated by Stat Rx USA on July 23, 2012 and is designated Class III. Reason for recall: Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label. The recall status is terminated (terminated January 31, 2013). Affected quantity: 51 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 1, 2012
- Initiation Date
- July 23, 2012
- Termination Date
- January 31, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51 Bottles
Product Description
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.
Reason for Recall
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Distribution Pattern
Nationwide
Code Information
Lot #: 28JN1272, Exp 02/15