Drug 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)
D-0003-2023
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 90903
- Status
- Terminated
- Classification
- Class II
- Quantity
- 103,150 10 mL vials
- Official record key
drug-enforcement:D-0003-2023
Official wording
Reason: Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Code information: Lot: 30-137-DK Exp. 1 DEC. 2022
Distribution pattern: Distributed in the United States and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter