FDAFDA · Food and drugs·Recall number D-1067-2013
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.
Published October 9, 2013 · Recall initiated: September 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Osmotica Pharmaceutical Corp
- Distributor
- Nationwide
- Lot
- Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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