Recalls / Class II
Class IID-0223-2024
Product
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 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 #: T2304007, Exp 7/31/2026
Why it was recalled
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
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, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 38,952 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-01-02
- FDA classified
- 2024-01-11
- Posted by FDA
- 2024-01-17
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0223-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.