Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409
Summary
The FDA issued a Class II for Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Lab by Dr. Reddy's Laboratories, Inc.. Reason: Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets..
Details
Source
Drug Recall
External ID
D-0223-2024
Action Date
2024-01-17
Status
Completed
Category
drug
Product Description
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15
Lot/Code Info: Lot #: T2304007, Exp 7/31/2026
Quantity Affected: 38,952 bottles
Reason for Recall
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-02
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 20 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dr. Reddy's Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dr. Reddy's Laboratories, Inc. have FDA actions?
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0223-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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