Recalls / Class II
Class IID-1191-2018
Product
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
- 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 #: T800304, Exp. 03/2021
Why it was recalled
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl 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, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 8376 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2018-09-04
- FDA classified
- 2018-09-17
- Posted by FDA
- 2018-09-26
- Terminated
- 2022-03-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1191-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.