D-0579-2024 Class II Terminated

Recalled by Trigen Laboratories — Alpharetta, GA

Recall Details

Product Type
Drugs
Report Date
July 10, 2024
Initiation Date
June 17, 2024
Termination Date
September 23, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,448 100-count bottles

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

Reason for Recall

Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

Distribution Pattern

Nationwide in the USA

Code Information

Lot 230159M, Exp Date 2/28/2026