Drug recall D-0579-2024

Class II Terminated reported Jul 10, 2024

Product

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.

Lots and codes

Lot 230159M, Exp Date 2/28/2026

Recall details

Recalling firm
Trigen Laboratories, Alpharetta, GA
Quantity
10,448 100-count bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
June 17, 2024
Terminated
September 23, 2025

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