Drug product
Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
D-834-2013
Product summary
- Event
- Event 49085
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3,720 capsules total
- Official record key
drug-enforcement:D-834-2013
Official wording
Reason: 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.
Code information: No lot codes are printed on the product
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.