FDA Drug recall D-834-2013
Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8)
- FDA Drug
- Class I
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class I recall of Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8) by Chang Kwung Products, citing 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 a….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-834-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-05-06 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Chang Kwung Products |
| Distribution | US |
Product
Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
Reason
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.
Identifiers
| upc | 689076202978 |
|---|---|
| code_info | No lot codes are printed on the product |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-834-2013%22
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