Recall Enforment Report D-1344-2022
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Nephron Sterile Compounding Center LLC, originally initiated on 08-10-2022 for the product PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33 The product was recalled due to cgmp deviations: potential for cross-contamination due to product carryover during manufacturing.. The product was distributed nationwide and the recall is currently completed.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-1344-2022 | 08-10-2022 | 08-24-2022 | Class II | 13,500 vials | PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33 | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Completed |
D-1345-2022 | 08-10-2022 | 08-24-2022 | Class II | 294 bags | Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04 | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Completed |
D-1346-2022 | 08-10-2022 | 08-24-2022 | Class II | 2030 bags | PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05 | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Completed |
D-1347-2022 | 08-10-2022 | 08-24-2022 | Class II | 33,870 vials | PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34 | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Completed |