Reported Mar 14, 2018 · Terminated

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

Osmotica Pharmaceutical Corp.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Osmotica Pharmaceutical Corp · 895 Sawyer Rd · Marietta, GA · 30062-2257

Is this the product you have?

  • Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
Lot codes and dates
  • Lots
    • 170231B
    • 170232A
    • 170233A
    • 170234A
Amount recalled
19,664 100-bottles

Where it was sold

  • Nationwide

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 1, 2019 · Data as of Sep 19, 7:59 PM UTC

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