Drug recall
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by…
FDA recall event 90903 · Class II · Pfizer Inc.
Key facts
| Event ID | 90903 |
|---|---|
| Recall numbers | D-0003-2023 |
| Recalling firm | Pfizer Inc. |
| Product type | Drugs |
| Products | 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) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. |
| Initiation date | Sep 27, 2022 |
| Report date | Oct 12, 2022 |
| Termination date | Aug 21, 2024 |
| City | New York |
| State | NY |
| Country | United States |
| FEI number | 2416101 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: