Drug recall
MED-341 Simethicone Emulsion USP, 30%, a) 16 oz (0.45 kg)glass bottle, b) 5 gallon (18.0 kg)plastic pail, c)…
FDA recall event 58638 · Class II · NuSil Technology, LLC
Key facts
| Event ID | 58638 |
|---|---|
| Recall numbers | D-851-2011 |
| Recalling firm | NuSil Technology, LLC |
| Product type | Drugs |
| Products | MED-341 Simethicone Emulsion USP, 30%, a) 16 oz (0.45 kg)glass bottle, b) 5 gallon (18.0 kg)plastic pail, c) 55 gallon (210 kg) plastic drum, NuSil Technology- Bakersfield, 2343 Pegasus Drive… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Microbial Contamination of Non-Sterile Products: Certain lots of the product were confirmed to have exceeded the USP specification for maximum microbial content (microbial type, Burkholderia Cepacia). |
| Initiation date | Apr 4, 2011 |
| Termination date | Nov 22, 2011 |
| City | Bakersfield |
| State | CA |
| Country | United States |
| FEI number | 3005140091 |
At a glance
- 1–9 Products in this recall
- 1–9 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