Recall record at a glance
| Official record | D-323-2013 |
|---|---|
| Category | Drug Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | D& S Herbals, LLC |
| Report date | May 22, 2013 |
| Recall initiation date | Dec 22, 2012 |
| Quantity | 40,480 blister packs |
| Location | Woodbridge, NJ, United States |
Official product description
Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9.
Why the product was recalled
Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug.
Distribution information
Nationwide
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Press Release.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.