FDA Drug recall D-0003-2023
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc
- FDA Drug
- Class II
- terminated
- Published 2022-10-12
On 2022-10-12 the FDA classified a Class II recall of Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc by Pfizer, citing presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0003-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-09-27 |
| Published | 2022-10-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | PR |
Product
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)
Reason
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Identifiers
| ndc | 0409-5921-16 |
|---|---|
| ndc | 0409-5921-01 |
| ndc | 0409-5922-16 |
| ndc | 0409-5922-01 |
| code_info | Lot: 30-137-DK Exp. 1 DEC. 2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0003-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.