FDA-Drug2013-08-14Class I
Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
Chang Kwung Products
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.
Sold states
Nationwide
Affected count
3,720 capsules total
Manufactured in
24200 Albers St, N/A, Woodland Hills, CA, United States
Products
Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-834-2013Don't want to check this manually?
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