Aminophylline Injection — Class II drug recall D-0003-2023
Terminated recall by Pfizer Inc., reported 2022-10-12, distributed in PR. Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
| Recall number | D-0003-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2022-09-27 |
| Classified | 2022-10-04 |
| Reported by FDA | 2022-10-12 |
| Terminated | 2024-08-21 |
| Distributed | PR |
| Quantity | 103,150 |
| Reason classes | specification failure |
| NDC | 00409-5921, 00409-5921-01, 00409-5921-16, 00409-5922, 00409-5922-01, 00409-5922-16 |
| Lot numbers | 30-137-DK |
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 for recall
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0003-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.