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.
Reported: October 9, 2013 Initiated: September 16, 2013 #D-1067-2013
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.
Details
- Recalling Firm
- Osmotica Pharmaceutical Corp
- Units Affected
- 57857 bottles
- Distribution
- Nationwide
- Location
- Marietta, GA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Osmotica Pharmaceutical Corp. Units affected: 57857 bottles.
Why was this product recalled? ▼
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 9, 2013. Severity: Low. Recall number: D-1067-2013.
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