Drug recall
GRISEOFULVIN ORAL SUSPENSION, USP (Microsize), 125mg/5mL, CONTAINS 0.2% ALCOHOL, Rx only, 4 fl oz (118 mL)…
FDA recall event 59230 · Class II · Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Key facts
| Event ID | 59230 |
|---|---|
| Recall numbers | D-986-2011, D-987-2011, D-988-2011 |
| Recalling firm | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals |
| Product type | Drugs |
| Products | GRISEOFULVIN ORAL SUSPENSION, USP (Microsize), 125mg/5mL, CONTAINS 0.2% ALCOHOL, Rx only, 4 fl oz (118 mL), Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 NDC 0603-9171-54, Infants' Simethicone Drops, Active Ingredient (in each 0.3 mL) Simethicone 20 mg, 100 Doses, 1 FL OZ (30mL) bottle, Qualitest Pharmaceuticals, Huntsville, AL, 35811, NDC 0603-0894-50, TRIAMCINOLONE ACETONIDE LOTION, USP 0.1%, EACH mL PROVIDES: 1 mg of triamcinolone acetonide, 60 mL, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7864-49 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Microbial contamination of Non Sterile Product; product may be contaminated with Burkholderia cepacia., Microbial Contamination of Non Sterile Product; product may be contaminated with Burkholderia cepacia. |
| Initiation date | Jun 30, 2011 |
| Termination date | Mar 1, 2012 |
| City | Huntsville |
| State | AL |
| Country | United States |
| FEI number | 1000524784 |
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