Drug recall
Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b)…
FDA recall event 62772 · Class II · Prometheus Laboratories Inc.
Key facts
| Event ID | 62772 |
|---|---|
| Recall numbers | D-1659-2012 |
| Recalling firm | Prometheus Laboratories Inc. |
| Product type | Drugs |
| Products | Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution. |
| Initiation date | Jun 29, 2012 |
| Report date | Aug 29, 2012 |
| Termination date | Mar 27, 2013 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 3003586938 |
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 · Source date: