D-834-2013 Class I Terminated
FDA drug recall D-834-2013 was initiated by Chang Kwung Products on May 6, 2013 and is designated Class I. 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 … The recall status is terminated (terminated September 19, 2014). Affected quantity: 3,720 capsules total.
Recall Details
- Product Type
- Drugs
- Report Date
- August 14, 2013
- Initiation Date
- May 6, 2013
- Termination Date
- September 19, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,720 capsules total
Product Description
Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
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.
Distribution Pattern
Nationwide
Code Information
No lot codes are printed on the product