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

FDA recall notice · announced August 14, 2013 · Chang Kwung Products

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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

Reason for recall

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.

Notes

Distribution: Nationwide
Lot/code information: No lot codes are printed on the product
Quantity: 3,720 capsules total
Status: Terminated
Products in this recall event:
- Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8). (D-834-2013)
- Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2). (D-833-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.