FDA Drug recall D-0281-2021
MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray…
- FDA Drug
- Class II
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class II recall of MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray… by Teva Pharmaceuticals Usa, citing lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0281-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-10 |
| Published | 2021-03-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
MethyIPREDNISolone 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.
Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Identifiers
| code_info | Lot # 31327909B, exp. date 04/2021 Lot # 31328352B, exp. date 07/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0281-2021%22
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