Recall Enforment Report D-1332-2022
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by SterRx, LLC, originally initiated on 07-25-2022 for the product fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02. The product was recalled due to lack of assurance of sterility. 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-1332-2022 | 07-25-2022 | 08-17-2022 | Class II | 360 bags | fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02. | Lack of Assurance of Sterility | Terminated |
D-1331-2022 | 07-25-2022 | 08-17-2022 | Class II | 720 bags | FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01. | Lack of Assurance of Sterility | Terminated |