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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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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