Drug recall D-0581-2018

Class III Terminated reported Mar 14, 2018

Product

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

Reason for recall

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

Lots and codes

Lots: 170231B, 170232A, 170233A, 170234A

Recall details

Recalling firm
Osmotica Pharmaceutical Corp, Marietta, GA
Quantity
19,664 100-bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
February 28, 2018
Terminated
May 1, 2019

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