Recalls / Class II
Class IID-0003-2023
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)
- Brand name
- Aminophylline
- Generic name
- Aminophylline
- Active ingredient
- Aminophylline Dihydrate
- Route
- Intravenous
- NDCs
- 0409-5921, 0409-5922
- FDA application
- ANDA087242
- Affected lot / code info
- Lot: 30-137-DK Exp. 1 DEC. 2022
Why it was recalled
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 103,150 10 mL vials
- Distribution pattern
- Distributed in the United States and Puerto Rico.
Timeline
- Recall initiated
- 2022-09-27
- FDA classified
- 2022-10-04
- Posted by FDA
- 2022-10-12
- Terminated
- 2024-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0003-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.