Aminophylline Injection Recalled for Particulate Matter
Pfizer is recalling Aminophylline Injection vials due to a complaint of particulate matter (hair) in one vial. Over 103,000 vials were distributed to the US and Puerto Rico.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving particulate matter contamination in a parenteral injectable drug, representing a risk-of-harm product. No illnesses or injuries have been reported. Per the severity rubric, when the hazard is theoretical and no harm is documented, the maximum score is 3.
Plain-English summary
Pfizer Inc. has recalled Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) due to a reported complaint of particulate matter contamination. A complaint was received indicating the presence of a hair in one vial.
The recall involves 103,150 10 mL single-dose vials (Lot 30-137-DK, expiration 1 December 2022) distributed in the United States and Puerto Rico. The product is a prescription intravenous injection.
Particulate matter in a parenteral injectable could potentially cause harm if the affected vials are administered. Healthcare providers with affected lots should verify inventory against the recalled lot number and not use vials from Lot 30-137-DK.
The recalled product
- Product
- AMINOPHYLLINE (AMINOPHYLLINE)
- Brand
- AMINOPHYLLINE
- Manufacturer
- Pfizer Inc.
- Category
- Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 30-137-DK Exp. 1 DEC. 2022
Distribution
Distributed in 1 state:
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