Why it was recalled
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.
Product description
Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).
Lot numbers, UPCs & expiration codes
No lot codes are printed on the product
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-833-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 6, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 3,720 capsules total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Chang Kwung Products
Original FDA data
Every field from FDA enforcement report D-833-2013, exactly as published.
Show all FDA fields
- City
- Woodland Hills
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 49085
- Address
- 24200 Albers St
- Code information
- No lot codes are printed on the product
- Postal code
- 91367-5704
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-833-2013
- Classification
- Class I
- Recalling firm
- Chang Kwung Products
- Product quantity
- 3,720 capsules total
- Termination date
- Sep 19, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).
- Distribution pattern
- Nationwide
- Recall initiation date
- May 6, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2013