Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam -
Summary
The FDA issued a Class II for Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Re by Dr Reddy's Laboratories Limited. Reason: Failed dissolution specification: Out of specification results observed in 24-month long term stability testing..
Details
Source
Drug Recall
External ID
D-0923-2023
Action Date
2023-07-26
Status
Ongoing
Category
drug
Product Description
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
Lot/Code Info: Lot: T2100585, T2100586, T2100587, Exp 12/2023
Quantity Affected: 17,548 1000-countbottles
Reason for Recall
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Distribution
Nationwide in the USA
Type: N/A
Recall Initiated: 2023-06-21
Company
Ranasthalam Mandal, Srikakulam, N/A
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 71 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 Limited) 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 Limited have FDA actions?
This is the only FDA action we have on record for Dr Reddy's Laboratories Limited in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0923-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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