Class I
Terminated
XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012
This recall has been terminated (originally issued September 24, 2014).
- Company
- Nova Products, Inc.
- Recall Initiated
- March 28, 2014
- Posted
- September 24, 2014
- Recall Number
- D-1599-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- Unknown
- Firm Location
- Aston, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Distribution
Nationwide to retailers and distributors
Lot / Code Info
Lot# 130520PL
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