Osmotica Pharmaceutical Corp recalls Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC…

Recall date

February 28, 2018

Source

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

Recall number

D-0581-2018

FDA classification

Class III

Brand / firm

Osmotica Pharmaceutical Corp

Sold / distributed

Nationwide in the USA

Why it was recalled

Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10