FDA Drug recall D-0277-2021
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray…
- FDA Drug
- Class II
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class II recall of Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use 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-0277-2021 |
| 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
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618.
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
| ndc | 0703-4502-01 |
|---|---|
| ndc | 0703-4502-04 |
| code_info | Lot # 31325042B, exp. date 06/2021 31325336B, exp. date 07/2021 31326042B, exp. date 10/2021 31326137B, exp. dat…Lot # 31325042B, exp. date 06/2021 31325336B, exp. date 07/2021 31326042B, exp. date 10/2021 31326137B, exp. date 11/2021 31326230B, exp. date 12/2021 31323816B, exp. date 02/2021 |
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-0277-2021%22
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