Product Detail

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

Recall Number D-834-2013

Classification Class I

Code Info No lot codes are printed on the product

Product Distributed Qty 3,720 capsules total

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.

Event Detail

Event Id 49085

Product Type Drugs

Status Ongoing

Recalling Firm

Chang Kwung Products

City Woodland Hills
State CA
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-05-06

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide