Why it was recalled
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Product description
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153
Lot numbers, UPCs & expiration codes
Lot #: T800304, Exp. 03/2021
Where it was sold
Nationwide within the United States
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-1191-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2018
- FDA report date
- Sep 26, 2018
- Quantity
- 8376 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1191-2018, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80953
- Address
- 107 College Rd E
- Code information
- Lot #: T800304, Exp. 03/2021
- Postal code
- 08540-6623
- Report date
- Sep 26, 2018
- Product type
- Drugs
- Recall number
- D-1191-2018
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 8376 units
- Termination date
- Mar 1, 2022
- Reason for recall
- Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 4, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2018