Skip to content
Recall Observatory FDA recall evidence

Drug product

Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).

D-833-2013

May 06, 2013

Class I

Product summary

Firm
Chang Kwung Products
Event
Event 49085
Status
Terminated
Classification
Class I
Quantity
3,720 capsules total
Official record key
drug-enforcement:D-833-2013

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

    reason.no_named_rule · v1.0.0

    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.