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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Aminophylline Injection Recalled for Presence of Hair in Vial

Agency Publication Date: October 4, 2022
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Summary

Pfizer Inc. has recalled 103,150 vials of Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) after a complaint was received regarding the presence of a hair in one vial. This prescription medication is used to treat respiratory conditions and was distributed by Hospira, Inc. throughout the United States and Puerto Rico. While one complaint has been received, no injuries or illnesses have been reported to date in connection with this issue.

Risk

The presence of particulate matter like hair in a sterile injectable drug can cause inflammation, allergic reactions, or blood vessel blockages. If a particle travels through the bloodstream to vital organs, it could lead to serious medical complications.

What You Should Do

  1. The recalled product is Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) in 10 mL single-dose vials, identified by NDC 0409-5921-16 (vial) and 0409-5921-01 (carton).
  2. Check the vial or carton for lot number 30-137-DK with an expiration date of 1 DEC. 2022.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer or your distributor to arrange for the return of any remaining affected product.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Aminophylline Injection, USP (250 mg/10 mL)
Variants: 25 mg/mL, 10 mL Single-dose vial
Lot Numbers:
30-137-DK (Exp 1 DEC. 2022)
NDC:
0409-5921-16
0409-5921-01

Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. Single-dose vial, Rx only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90903
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Hospira, Inc.
Manufactured In: United States
Units Affected: 103,150 10 mL vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.