Drug recall
EXPANDED GAG, SPL Scientific Protein Laboratories LLC, 700 East Main Street, Waunakee, Wisconsin 53597-0158…
FDA recall event 57006 · Class II · Scientific Protein Laboratories, LLC
Key facts
| Event ID | 57006 |
|---|---|
| Recall numbers | D-213-2011, D-214-2-11 |
| Recalling firm | Scientific Protein Laboratories, LLC |
| Product type | Drugs |
| Products | EXPANDED GAG, SPL Scientific Protein Laboratories LLC, 700 East Main Street, Waunakee, Wisconsin 53597-0158 USA. Caution: For Manufacturing, Processing or Repackaging. Preserve in tight containers and…, Heparin Sodium, USP (Porcine Intestines), SPL Scientific Protein Laboratories LLC, 700 East Main Street, Waunakee, Wisconsin 53597-0158 USA. Caution: For Manufacturing and Processing use only. Federal… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | SPL is initiating this recall because additional testing of retained samples of this API lot (1035-0771) indicated a small amount of oversulfated chondroitin sulfate (OSCS). Lots 1035-0778 and… |
| Initiation date | Oct 15, 2010 |
| Termination date | Apr 13, 2021 |
| City | Waunakee |
| State | WI |
| Country | United States |
| FEI number | 2111173 |
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