US Drug Recall Register
Class I · High risk Terminated Initiated May 6, 2013 (13 years ago)

Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

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 was recalled

Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).

Recalling firm
Chang Kwung Products
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-834-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.