Status
Terminated
Drug Enforcement D-238-2013
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Classification
Class III
Report Date
April 10, 2013
Termination Date
February 6, 2014
Product Information
- Product description
- 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.
- Product quantity
- 117,546 bottles
- Reason for recall
- Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Dr. Reddy'S Laboratories
- Address
-
200 Somerset Corporate Blvd FL 7, Blvd 11 7th Floor
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-238-2013
- Event ID
- 64733
- Recall initiation date
- March 19, 2013
- Center classification date
- April 1, 2013
- Code info
- Lot #: C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15.
- More code info
- —