D-0003-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 12, 2022
- Initiation Date
- September 27, 2022
- Termination Date
- August 21, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 103,150 10 mL vials
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)
Reason for Recall
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Distribution Pattern
Distributed in the United States and Puerto Rico.
Code Information
Lot: 30-137-DK Exp. 1 DEC. 2022