The Recall Desk
CriticalFDA (Drugs)·D-834-2013·Announced 2013-08-14

Lightning ROD capsules recalled for undeclared sildenafil analogue

Chang Kwung Products is recalling Lightning ROD capsules because FDA analysis found an undeclared analogue of sildenafil, making the product an unapproved new drug.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Chang Kwung Products is recalling Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles. The recall involves 3,720 capsules distributed nationwide. No lot codes are printed on the product.

The recall was initiated because FDA analysis found the product contains an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction. Consequently, the Lightning ROD capsules are considered an unapproved new drug.

Consumers should stop using the product and return it to the place of purchase.

The recalled product

Product
Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
Affected units
3,720

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • No lot codes are printed on the product

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Chang Kwung Products under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Chang Kwung Products

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