Drug recall
Hepatitis B Vaccine (Recombinant)
FDA recall event 68127 · Class II · Merck Sharpe & Dohme Corp
Key facts
| Event ID | 68127 |
|---|---|
| Recall numbers | B-0625-14 |
| Recalling firm | Merck Sharpe & Dohme Corp |
| Product type | Biologics |
| Products | Hepatitis B Vaccine (Recombinant) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Recombivax HB, one lot with the potential for a crack to have occurred in the vial, was distributed. |
| Initiation date | Jun 26, 2013 |
| Report date | May 7, 2014 |
| Termination date | Aug 26, 2014 |
| City | West Point |
| State | PA |
| Country | United States |
| FEI number | 2510592 |
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 · Source date: