FDA Recalls NDC 0703-0051 Methylprednisolone Acetate
Injection, Suspension Intra-articular; Intralesional; Intramuscular; Soft Tissue

FDA Recalls Enforcement Reports

The last Recall Enforcement Report for Methylprednisolone Acetate with NDC 0703-0051 was initiated on 04-13-2022 as a Class II recall due to cgmp deviations: temperature abuse The latest recall number for this product is D-1070-2022 and the recall is currently ongoing .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1070-202204-13-202206-15-2022Class II983 cartons/1 vial each and 107 cartons/25 vials eachMethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0031-01), b) 25-count box (NDC 0703-0031-04), Rx only, MFG: Teva Pharma USAOngoing
D-1073-202204-13-202206-15-2022Class II1088 cartons/1 vial each and 63 cartons/25 vials eachMethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0051-01) b) 25-count box (NDC 0703-0051-04), Rx only, MFG: Teva Pharma USAOngoing
D-0743-202107-29-202108-25-2021Class II50,713 vialsMethylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.Ongoing
D-0731-202107-29-202108-25-2021Class II193,845 vialsMethylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.Ongoing
D-0281-202102-10-202103-03-2021Class II5,378 vialsMethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.Ongoing
D-0275-202102-10-202103-03-2021Class II5,086 vialsMethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.Ongoing

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.