Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 0
Summary
The FDA issued a Class II for Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharm by SUN PHARMACEUTICAL INDUSTRIES INC. Reason: Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing.
Details
Source
Drug Recall
External ID
D-0914-2023
Action Date
2023-07-19
Status
Terminated
Category
drug
Product Description
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
Lot/Code Info: Lot HAC3339A, Expires 07/2023
Quantity Affected: 8,880 30-count bottles
Reason for Recall
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Distribution
Distributed nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-10
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 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 clearance.
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 (SUN PHARMACEUTICAL INDUSTRIES INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUN PHARMACEUTICAL INDUSTRIES INC have FDA actions?
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0914-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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