Trigen Laboratories recalls Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen…

Recall date

June 17, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0579-2024

FDA classification

Class II

Brand / firm

Trigen Laboratories

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10