Drug recall
Haloperidol Injection, USP, 5 mg/mL, 1 mL vial, Rx Only, For Intramuscular Use, Sterile; American…
FDA recall event 26993 · Class III · American Pharmaceutical Partners, Inc.
Key facts
| Event ID | 26993 |
|---|---|
| Recall numbers | D-328-3 |
| Recalling firm | American Pharmaceutical Partners, Inc. |
| Product type | Drugs |
| Products | Haloperidol Injection, USP, 5 mg/mL, 1 mL vial, Rx Only, For Intramuscular Use, Sterile; American Pharmaceutical Partners, Inc., Schaumburg, IL 60173; NDC 63323-474-01. The product was also sold under… |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Manufacturing Validation: The bulk solution mix time was not completed as per the validated process time |
| Initiation date | Aug 18, 2003 |
| City | Melrose Park |
| Country | United States |
| FEI number | 1000115163 |
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