Recalls / Class III
Class IIID-238-2013
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.
- Brand name
- Tizanidine
- Generic name
- Tizanidine
- Active ingredient
- Tizanidine Hydrochloride
- Route
- Oral
- NDCs
- 55111-179, 55111-180
- FDA application
- ANDA076286
- Affected lot / code info
- Lot #: C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15.
Why it was recalled
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Recalling firm
- Firm
- Dr. Reddy'S Laboratories
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Somerset Corporate Blvd FL 7, Blvd 11 7th Floor, Bridgewater, New Jersey 08807-2862
Distribution
- Quantity
- 117,546 bottles
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2013-03-19
- FDA classified
- 2013-04-01
- Posted by FDA
- 2013-04-10
- Terminated
- 2014-02-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-238-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.