Multi event Drug Recall Enforcement Report Class III voluntary initiated by Zydus Pharmaceuticals (USA) Inc, originally initiated on 07-02-2024 for the product Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box). The product was recalled due to cross contamination with other products. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0595-2024 | 07-02-2024 | 07-17-2024 | Class III | 12720 vials | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box). | Cross contamination with other products | Ongoing |
| D-0596-2024 | 07-02-2024 | 07-17-2024 | Class III | n/a | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box). | Cross contamination with other products | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 16714-164 | Micafungin | Micafungin | Injection, Powder, Lyophilized, For Solution | Intravenous | Northstar Rx Llc. | Human Prescription Drug |
| 16714-301 | Micafungin | Micafungin | Injection, Powder, Lyophilized, For Solution | Intravenous | Northstar Rx Llc. | Human Prescription Drug |
