Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen
Summary
The FDA issued a Class II for Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bo by Trigen Laboratories. Reason: Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications..
Details
Source
Drug Recall
External ID
D-0579-2024
Action Date
2024-07-10
Status
Terminated
Category
drug
Product Description
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
Lot/Code Info: Lot 230159M, Exp Date 2/28/2026
Quantity Affected: 10,448 100-count bottles
Reason for Recall
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-17
Company
Alpharetta, GA
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 53 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 (Trigen Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Trigen Laboratories have FDA actions?
This is the only FDA action we have on record for Trigen Laboratories in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0579-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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