Drug recall
PegIntron (Peginterferon alfa-2b) Powder for Injection REDIPEN Single-dose Delivery System, Powder for…
FDA recall event 56866 · Class II · Schering Corp
Key facts
| Event ID | 56866 |
|---|---|
| Recall numbers | D-085-2011, D-086-2011, D-087-2011, D-088-2011 |
| Recalling firm | Schering Corp |
| Product type | Drugs |
| Products | PegIntron (Peginterferon alfa-2b) Powder for Injection REDIPEN Single-dose Delivery System, Powder for Injection and Diluent (Sterile Water for Injection, USP); 120 mcg per 0.5 ml; one unit per…, PegIntron (Peginterferon alfa-2b) Powder for Injection REDIPEN Single-dose Delivery System, Powder for Injection and Diluent (Sterile Water for Injection, USP); 150 mcg per 0.5 ml; one unit per…, PegIntron (Peginterferon alfa-2b) Powder for Injection REDIPEN Single-dose Delivery System, Powder for Injection and Diluent (Sterile Water for Injection, USP); 50 mcg/0.5 ml; one unit per carton; Rx…, PegIntron (Peginterferon alfa-2b) Powder for Injection REDIPEN Single-dose Delivery System, Powder for Injection and Diluent (Sterile Water for Injection, USP);80 mcg per 0.5 ml; one unit per carton… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: There is potential for a low frequency defect in the glass cartridge component of the Redipen product delivery system in all strengths of Peg Intro (Peginterferon…, There is potential for a low frequency defect in the glass cartridge component of the Redipen product delivery system in all strengths of Peg Intro (Peginterferon alfa-2b) Powder for injection. |
| Initiation date | Sep 29, 2010 |
| Termination date | Oct 10, 2012 |
| City | Kenilworth |
| State | NJ |
| Country | United States |
| FEI number | 2210048 |
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