FDA Drug recall D-0305-2021
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intraveno…
- FDA Drug
- Class II
- terminated
- Published 2021-03-24
On 2021-03-24 the FDA classified a Class II recall of Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intraveno… by Sagent Pharmaceuticals, citing lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0305-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-11 |
| Published | 2021-03-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sagent Pharmaceuticals |
| Distribution | US |
Product
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.
Reason
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Identifiers
| ndc | 25021-315-01 |
|---|---|
| ndc | 25021-315-99 |
| ndc | 25021-315-98 |
| code_info | Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022 |
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-0305-2021%22
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