Status
Terminated
Drug Enforcement D-834-2013
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.
Classification
Class I
Report Date
August 14, 2013
Termination Date
September 19, 2014
Product Information
- Product description
- Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Chang Kwung Products
- Address
-
24200 Albers St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-834-2013
- Event ID
- 49085
- Recall initiation date
- May 6, 2013
- Center classification date
- August 2, 2013
- Code info
- No lot codes are printed on the product
- More code info
- —