Status
Terminated
Drug Enforcement D-1427-2012
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Classification
Class III
Report Date
August 1, 2012
Termination Date
January 31, 2013
Product Information
- 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.
- Product quantity
- 51 Bottles
- Reason for recall
- Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Stat Rx USA
- Address
-
2481 Hilton Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1427-2012
- Event ID
- 62639
- Recall initiation date
- July 23, 2012
- Center classification date
- July 26, 2012
- Code info
- Lot #: 28JN1272, Exp 02/15
- More code info
- —