FDA Recall D-833-2013
Chang Kwung Products · Woodland Hills, CA
Class I — life-threatening Terminated 501 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).
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 record
- Recall number
D-833-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2013-05-06
- Classified by FDA Center
- 2013-08-02
- FDA published
- 2013-08-14
- Terminated
- 2014-09-19
- Recalling firm
- Chang Kwung Products
- Firm location
- Woodland Hills, CA