Drug recall
Breckenridge Pharmaceuticals Sulfatol Gel 5%, Sodium Sulfacetamide 10% and Sulfur 5% 1.5 Fl. Oz.. (45 mL) Rx…
FDA recall event 35767 · Class III · Sheffield Laboratories, Div. of Faria Limited LLC
Key facts
| Event ID | 35767 |
|---|---|
| Recall numbers | D-311-6 |
| Recalling firm | Sheffield Laboratories, Div. of Faria Limited LLC |
| Product type | Drugs |
| Products | Breckenridge Pharmaceuticals Sulfatol Gel 5%, Sodium Sulfacetamide 10% and Sulfur 5% 1.5 Fl. Oz.. (45 mL) Rx only, NDC 51991-172-45 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Superpotent: sulfur levels exceeded the specifications of 4.5-5.5% |
| Initiation date | Jun 29, 2006 |
| Termination date | May 16, 2012 |
| City | New London |
| State | CT |
| Country | United States |
| FEI number | 1210513 |
At a glance
- 1–9 Products in this recall
- 10–99 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