Recalls / Class II
Class IID-0750-2021
Product
Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 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 #: T2000471, exp date 09/2023
Why it was recalled
Failed Tablet/Capsule Specification: Some tablets are shaved
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 37560 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-07-19
- FDA classified
- 2021-08-18
- Posted by FDA
- 2021-08-25
- Terminated
- 2022-12-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0750-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.