# FDA recall D-833-2013

> **Chang Kwung Products** · Class I · drug recall initiated 2013-05-06.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-833-2013
- **Recalling firm:** Chang Kwung Products
- **Classification:** Class I
- **Product type:** drug
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-833-2013

## Citation

> AI Analytics. FDA recall D-833-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-833-2013. Source: US FDA. Licensed CC0.

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