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)
Reported: October 12, 2022 Initiated: September 27, 2022 #D-0003-2023
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.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 103,150 10 mL vials
- Distribution
- Distributed in the United States and Puerto Rico.
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Pfizer Inc.. Units affected: 103,150 10 mL vials.
Why was this product recalled? ▼
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 12, 2022. Severity: Moderate. Recall number: D-0003-2023.
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