Drug recall
COMVAX (Haemophilus b conjugate[meningococcal protein conjugate] and Hepatitis B [recombinant] Vaccine) 7.5mcg…
FDA recall event 37491 · Class III · AmeriSource Bergen
Key facts
| Event ID | 37491 |
|---|---|
| Recall numbers | B-1576-07, B-1577-07, B-1578-07, B-1579-07 |
| Recalling firm | AmeriSource Bergen |
| Product type | Biologics |
| Products | COMVAX (Haemophilus b conjugate[meningococcal protein conjugate] and Hepatitis B [recombinant] Vaccine) 7.5mcg HIB/125mcg Neisseria Meningitidis/5mcg HBsAG per 0.5ml, 0.5 ml single dose vials, 10…, Pedvax HIB (Haemophilus b Conjugate Vaccine [Meningococcal Protein Conjugate]) 7.5mcg HIB/125mcg Neisseria Meningitidis/225mcg aluminum per 0.5ml, 0.5 ml single dose vials, 10 vials per pack. NDC…, Recombivax HB (Hepatitis B Vaccine [recombinant]) 40mcg/ml, single dose vials. NDC number 0006-4992-00; Recombivax HB Adult Formulation (Hepatitis B Vaccine [recombinant]) 10mcg/ml, 10 vials per pack…, VAQTA (Hepatitis A Vaccine [inactivated]) 50mcg/ml (Adult), single dose vials, 10 vials per pack. NDC number 0006-4841-41 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Vaccines, lacking assurance of appropriate storage temperatures during transit, were distributed. |
| Initiation date | Feb 28, 2007 |
| Termination date | Sep 25, 2007 |
| City | Chesterbrook |
| State | PA |
| Country | United States |
| FEI number | 3004459493 |
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