Drug recall
Amitriptyline HCl, 10mg, 1000 count bottles, Rx only, Mfg for: Qualitest Pharmaceuticals, Inc., Huntsville, AL…
FDA recall event 28928 · Class III · Vintage Pharmaceuticals Llc
Key facts
| Event ID | 28928 |
|---|---|
| Recall numbers | D-163-4 |
| Recalling firm | Vintage Pharmaceuticals Llc |
| Product type | Drugs |
| Products | Amitriptyline HCl, 10mg, 1000 count bottles, Rx only, Mfg for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Mfg by: Vintage Pharmaceuticals, LLC., Huntsville, AL 35811, NDC #0603-2212-32 |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities: impurity level exceeded at the 6 month stability point |
| Initiation date | Apr 7, 2004 |
| City | Huntsville |
| 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