FDA recall D-0579-2024

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2024-06-17

Report date

2024-07-10

Termination date

2025-09-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0579-2024