Drug recall
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for…
FDA recall event 63138 · Class I · Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Key facts
| Event ID | 63138 |
|---|---|
| Recall numbers | D-057-2013 |
| Recalling firm | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals |
| Product type | Drugs |
| Products | HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21 |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. |
| Initiation date | Sep 10, 2012 |
| Report date | Nov 28, 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 · Source date: