Drug recall
MESALAMINE RECTAL SUSPENSION, USP, ENEMA, 4g/60 mL, For Rectal Use Only, Rx only. Distributed under the Clay…
FDA recall event 33447 · Class III · Clay Park Labs Inc
Key facts
| Event ID | 33447 |
|---|---|
| Recall numbers | D-490-5 |
| Recalling firm | Clay Park Labs Inc |
| Product type | Drugs |
| Products | MESALAMINE RECTAL SUSPENSION, USP, ENEMA, 4g/60 mL, For Rectal Use Only, Rx only. Distributed under the Clay Park Labs (CPL) label. NDC 45802-098-51: 7 x 60 mL Unit-Dose Bottles, NDC 45802-098-28: 28… |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Container Leakage: Firm received numerous complaints of leaking bottles. |
| Initiation date | Sep 16, 2005 |
| City | Bronx |
| Country | United States |
| FEI number | 2450054 |
At a glance
- 1–9 Products in this recall
- 10–99 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