Drug recall
Entrobar Barium Sulfate Suspension, Rx Only, (50% w/v barium sulfate USP suspension...), Net Contents: 500 ml…
FDA recall event 27412 · Class II · Mallinckrodt Inc
Key facts
| Event ID | 27412 |
|---|---|
| Recall numbers | D-054-4, D-055-4, D-056-4, D-057-4 |
| Recalling firm | Mallinckrodt Inc |
| Product type | Drugs |
| Products | Entrobar Barium Sulfate Suspension, Rx Only, (50% w/v barium sulfate USP suspension...), Net Contents: 500 ml, Manufactured in the U.S.A. by: Lafayette Pharmaceuticals, Incorporated, Lafayette, IN…, Entrocel, Methylcellulose solution, (1.8% w/v hydroxpropyl methylcellulose solution...), For Professional Use Only, Net Contents: 500 ml, Manufactured in the U.S.A. by: Lafayette Pharmaceuticals…, Entrokit Enteroclysis Kit, Manufactured in the U.S.A. by: Lafayette Pharmaceuticals, Incorporated, Lafayette, IN 47904, NDC 59081-502-02 (This kit contains both Entrobar and Entrocel product), Entrokit Enteroclysis Kit with Catheter, Manufactured in the U.S.A. by: Lafayette Pharmaceuticals, Incorporated, Lafayette, IN 47904, NDC 59081-502-52. (This kit contains both Entrobar and Entrocel… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mislabeling: Entrobar labeled bottles may contain Entrocel (clear liquid) or Entrocel labeled bottles may contain Entrobar (milky-white liquid) |
| Initiation date | Sep 30, 2003 |
| City | Hazelwood |
| Country | United States |
| FEI number | 1925021 |
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