Multi event Drug Recall Enforcement Report Class II voluntary initiated by Hospira Inc., originally initiated on 09-24-2013 for the product Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03 The product was recalled due to presence of particular matter: potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-013-2014 | 09-24-2013 | 11-27-2013 | Class II | 681,400 vials | Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03 | Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials. | Terminated |
| D-012-2014 | 09-24-2013 | 11-27-2013 | Class II | 251,400 vials | Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01 | Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0409-3414 | Metoclopramide | Metoclopramide | Injection, Solution | Intramuscular; Intravenous | Hospira, Inc. | Human Prescription Drug |
| 0409-4755 | Ondansetron | Ondansetron | Injection, Solution | Intramuscular; Intravenous | Hospira, Inc. | Human Prescription Drug |
| 0409-4759 | Ondansetron | Ondansetron | Injection, Solution | Intramuscular; Intravenous | Hospira, Inc. | Human Prescription Drug |
