FDAFDA · Food and drugs·Recall number D-834-2013
Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
Published August 14, 2013 · Recall initiated: May 6, 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
Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Chang Kwung Products
- Distributor
- Nationwide
- Lot
- No lot codes are printed on the product
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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