D-1191-2018 Class II Terminated
FDA drug recall D-1191-2018 was initiated by Dr. Reddy's Laboratories, Inc. on Sep 4, 2018 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets . The recall status is terminated (terminated Mar 1, 2022). Affected quantity: 8376 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 26, 2018
- Initiation Date
- Sep 4, 2018
- Termination Date
- Mar 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8376 units
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
Reason for Recall
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: T800304, Exp. 03/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1191-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026