Recall archive / FDA drug enforcement
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc.... — FDA record D-0003-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Quantity
- 103,150 10 mL vials
- Agency-reported status
- Terminated
- Source record identifier
- D-0003-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: 30-137-DK Exp. 1 DEC. 2022 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed in the United States and Puerto Rico.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 12, 2022
- Recall initiation date
- Sep 27, 2022
- Center classification date
- Oct 4, 2022
- Termination date
- Aug 21, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.