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, an unapproved new drug.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 per the rubric.
Plain-English summary
Chang Kwung Products is recalling Lightning ROD capsules, 500 mg/capsule, packaged in 3-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 product is considered an unapproved new drug marketed without an approved NDA/ANDA.
Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).
- Manufacturer
- Chang Kwung Products
- Category
- Drug — Unapproved New Drug
- 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 →Related recalls
Same manufacturer · Chang Kwung Products
See all →- CriticalLightning ROD capsules recalled for undeclared sildenafil analogue
FDA (Drugs) · 2013-08-14
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