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
170231B170232A170233A170234A
- Lots
- 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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