Drug recall
Vitrase (hyaluronidase injection) Ovine, 200 USP Units/mL, Rx only, Distributed by: ISTA Pharmaceuticals…
FDA recall event 31225 · Class II · ISTA Pharmaceuticals Inc
Key facts
| Event ID | 31225 |
|---|---|
| Recall numbers | D-140-5 |
| Recalling firm | ISTA Pharmaceuticals Inc |
| Product type | Drugs |
| Products | Vitrase (hyaluronidase injection) Ovine, 200 USP Units/mL, Rx only, Distributed by: ISTA Pharmaceuticals, Inc., Irvine, CA 92618, Manufactured by: Alliance Medical Products, Inc., Irvine, CA 92618 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An unvalidated and unapproved filter for final sterile filtration of the product appears to have been used in the manufacture of the lot. |
| Initiation date | Feb 15, 2005 |
| City | Irvine |
| Country | United States |
| FEI number | 3003434767 |
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