Home / Recalls / Osmotica Pharmaceutical Corp / D-0581-2018

D-0581-2018 Class III Terminated

Recalled by Osmotica Pharmaceutical Corp — Marietta, GA

Recall Details

Product Type
Drugs
Report Date
March 14, 2018
Initiation Date
February 28, 2018
Termination Date
May 1, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19,664 100-bottles

Product Description

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.

Distribution Pattern

Nationwide in the USA

Code Information

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

Other recalls by Osmotica Pharmaceutical Corp

  • D-0110-2018 Class III — Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bot (December 18, 2017)
  • D-0111-2018 Class III — Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bot (December 18, 2017)
  • D-1067-2013 Class III — Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packag (September 16, 2013)