FDA-Drug2024-07-10Class II

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

Trigen Laboratories
Hazard

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

Sold states
Nationwide in the USA
Affected count
10,448 100-count bottles
Manufactured in
1880 Mcfarland Pkwy, ste 110, Alpharetta, GA, United States
Products
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10

Official notice

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

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