drugs Class III Updated 2013-10-09

Osmotica Pharmaceutical Corp recalls Venlafaxine (Venlafaxine Hydrochloride) extended release Tab

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14
View official government recall

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