Status
Terminated
Drug Enforcement D-0003-2023
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
1 Views
Classification
Class II
Report Date
October 12, 2022
Termination Date
August 21, 2024
Product Information
- Product description
- 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)
- Product quantity
- 103,150 10 mL vials
- Reason for recall
- Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Distributed in the United States and Puerto Rico.
Location & Firm
- Recalling firm
- Pfizer Inc.
- Address
-
235 East 42nd Street, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0003-2023
- Event ID
- 90903
- Recall initiation date
- September 27, 2022
- Center classification date
- October 4, 2022
- Code info
- Lot: 30-137-DK Exp. 1 DEC. 2022
- More code info
- —