Home / Recalls / Osmotica Pharmaceutical Corp / D-1067-2013

D-1067-2013 Class III Terminated

Recalled by Osmotica Pharmaceutical Corp — Marietta, GA

Recall Details

Product Type
Drugs
Report Date
October 9, 2013
Initiation Date
September 16, 2013
Termination Date
May 9, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
57857 bottles

Product Description

Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA.

Reason for Recall

Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.

Distribution Pattern

Nationwide

Code Information

Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14

Other recalls by Osmotica Pharmaceutical Corp

  • D-0581-2018 Class III — Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bo (February 28, 2018)
  • 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)