Aminophylline Injection (Pfizer) – particulate contamination (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Pfizer Inc.
Lot Codes / Batch Numbers
Lot: 30-137-DK Exp. 1 DEC. 2022
Products Sold
Lot: 30-137-DK Exp. 1 DEC. 2022
Pfizer Inc. is recalling Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distribute due to Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026