FDA-Drug2013-10-09Class III
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.
Osmotica Pharmaceutical Corp
Hazard
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Sold states
Nationwide
Affected count
57857 bottles
Manufactured in
895 Sawyer Rd, Marietta, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1067-2013Don't want to check this manually?
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