FDA recall D-834-2013

Product

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

Nationwide

Key facts

Status

Terminated

Initiation date

2013-05-06

Report date

2013-08-14

Termination date

2014-09-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Woodland Hills, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-834-2013