drugs Class I Updated 2013-08-14

Chang Kwung Products recalls Lightning ROD capsules, 550 mg/capsule, packaged in 12-count

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: No lot codes are printed on the product
View official government recall

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