Recall Enforment Report D-0362-2023
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Nephron Sterile Compounding Center LLC, originally initiated on 02-22-2023 for the product Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25. The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
Recall Number | Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0362-2023 | 02-22-2023 | 03-08-2023 | Class II | 10,980 bottles | Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25. | Lack of Assurance of Sterility | Ongoing |
D-0357-2023 | 02-22-2023 | 03-08-2023 | Class II | 305,895 bottles | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25. | Lack of Assurance of Sterility | Ongoing |
D-0358-2023 | 02-22-2023 | 03-08-2023 | Class II | 270,291 bottles | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25. | Lack of Assurance of Sterility | Ongoing |
D-0356-2023 | 02-22-2023 | 03-08-2023 | Class II | 443,483 bottles | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25. | Lack of Assurance of Sterility | Ongoing |
D-0361-2023 | 02-22-2023 | 03-08-2023 | Class II | 24,870 vials | Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10. | Lack of Assurance of Sterility | Ongoing |
D-0355-2023 | 02-22-2023 | 03-08-2023 | Class II | 4,743 bottles | Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15. | Lack of Assurance of Sterility | Ongoing |
D-0359-2023 | 02-22-2023 | 03-08-2023 | Class II | 546,450 vials | Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10. | Lack of Assurance of Sterility | Ongoing |
D-0360-2023 | 02-22-2023 | 03-08-2023 | Class II | 31,500 vials | Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10. | Lack of Assurance of Sterility | Ongoing |