Reported Oct 9, 2013 · Terminated
Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC…
Osmotica Pharmaceutical Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Osmotica Pharmaceutical Corp · 895 Sawyer Rd · Marietta, GA · 30062
Is this the product you have?
- Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32)
- and b) 90-count bottle (NDC0131-3268-46), Rx only
- Manufactured byKremers Urban Pharmaceuticals Inc
- ForOsmotica Pharmaceutical Corp., Wilmington, NC 28405, USA
- Lot codes and dates
Lot #: a) 58975589765897765165Exp 01/14b) 589735897465131
- Exp01/14
- Amount recalled
- 57857 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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