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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

Advanced Pharma Inc.: Fentanyl (0.9% Sodium Chloride) Injectable Recalled for Incorrect Expiration Date

Agency Publication Date: February 15, 2019
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Summary

Advanced Pharma Inc. is recalling 100 units of Fentanyl in 0.9% Sodium Chloride (5 mcg/0.5 mL) injectable solution, a sterile single-use syringe. This recall was initiated because the product was labeled with an incorrect expiration date, which could lead to the use of a drug that has lost its potency or safety profile over time. These syringes were distributed specifically in Pennsylvania under the Avella of Houston brand.

Risk

The incorrect expiration date on the label may cause healthcare providers or patients to use the medication beyond its intended shelf life. Using expired Fentanyl can result in decreased effectiveness of the pain medication, potentially leading to inadequate pain management for the patient.

What You Should Do

  1. Immediately check your supply for Avella of Houston Fentanyl in 0.9% Sodium Chloride (5 mcg/0.5 mL) injectable syringes with NDC 42852-210-72.
  2. Verify the lot information: this recall specifically affects Lot# 12/31/18 0555 21072S with the expiration date 3/31/2019.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you have this medication in your possession.
  4. Return any unused product to the pharmacy or place of purchase for a refund and contact Advanced Pharma Inc. at (877) 794-0404 for further instructions.
  5. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL (0.5 mL syringe with up to 0.1 mL overfill)
Model:
NDC 42852-210-72
Recall #: D-0496-2019
Lot Numbers:
12/31/18 0555 21072S (Exp 3/31/2019)
Date Ranges: 3/31/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82130
Status: Resolved
Manufacturer: Advanced Pharma Inc.
Sold By: Avella of Houston
Manufactured In: United States
Units Affected: 100 syringes
Distributed To: Pennsylvania

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 · 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.