Drug recall
Oxybutynin Chloride Tablets, 5mg, 100 tablet bottles, Rx only, NDC 0182-1289-89. Manufactured by PLIVA, Inc…
FDA recall event 37802 · Class III · IVAX Pharmaceuticals
Key facts
| Event ID | 37802 |
|---|---|
| Recall numbers | D-799-2007 |
| Recalling firm | IVAX Pharmaceuticals |
| Product type | Drugs |
| Products | Oxybutynin Chloride Tablets, 5mg, 100 tablet bottles, Rx only, NDC 0182-1289-89. Manufactured by PLIVA, Inc., East Hanover, NJ 07936 for Goldline Laboratories Inc., Miami, FL 33137, a subsidairy of… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product does not meet dissolution specifications. |
| Initiation date | Apr 6, 2007 |
| Termination date | May 3, 2012 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 1000140211 |
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