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.
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.
Lot numbers, UPCs & expiration codes
Lot #: C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15.
Where it was sold
Nationwide and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-238-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 19, 2013
- FDA report date
- Apr 10, 2013
- Quantity
- 117,546 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy'S Laboratories
Original FDA data
Every field from FDA enforcement report D-238-2013, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64733
- Address
- 200 Somerset Corporate Blvd FL 7
- Address (line 2)
- Blvd 11 7th Floor
- Code information
- Lot #: C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15.
- Postal code
- 08807-2862
- Report date
- Apr 10, 2013
- Product type
- Drugs
- Recall number
- D-238-2013
- Classification
- Class III
- Recalling firm
- Dr. Reddy'S Laboratories
- Product quantity
- 117,546 bottles
- Termination date
- Feb 6, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Mar 19, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 1, 2013