Recall Enforment Report D-0371-2022
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA, originally initiated on 12-31-2021 for the product Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03. The product was recalled due to lack of assurance of sterility. The product was distributed in Methylprednisolone, Tn Norepinephrine Bitartrate - Ms, Oh 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-0371-2022 | 12-31-2021 | 01-19-2022 | Class II | 11,450 vials | Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03. | Lack of Assurance of Sterility | Terminated |
| D-0370-2022 | 12-31-2021 | 01-19-2022 | Class II | 7,400 cartons | MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons. | Lack of Assurance of Sterility | Terminated |
