Drug recall
Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo…
FDA recall event 64878 · Class I · Affirm XL, Inc.
Key facts
| Event ID | 64878 |
|---|---|
| Recall numbers | D-015-2014 |
| Recalling firm | Affirm XL, Inc. |
| Product type | Drugs |
| Products | Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male… |
| Initiation date | Apr 10, 2013 |
| Report date | Nov 27, 2013 |
| Termination date | Nov 27, 2013 |
| City | Ladera Ranch |
| State | CA |
| Country | United States |
| FEI number | 3010121561 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: