FDAFDA · Food and drugs·Recall number D-0880-2018
7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
Published June 6, 2018 · Recall initiated: May 17, 2018
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
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Shoreside Enterprises Inc.
- Distributor
- Nationwide.
- Lot
- Lot #: RO, Exp. 12/31/2021
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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