Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

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.

© 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Advanced Pharma Inc.: HEPERAIN Injectable Solution Recalled for Labeling Error on Concentration

Agency Publication Date: January 24, 2019
Share:
Sign in to monitor this recall

Summary

Advanced Pharma Inc. is recalling approximately 160 syringes of HEPERAIN (Heparin Sodium) 50 mg/50 mL (1mg/mL) Injectable Solution. The recall was initiated because the product labels incorrectly state the concentration as 50 mg/50 mL (1 mg/mL) when the actual, accurate concentration is 50 Units/50 mL (1 Unit/mL). This mislabeling affects product with lot number 12/19/18 0242 72565S and was distributed to facilities in Texas and Washington. Consumers and healthcare providers should check their inventory immediately for this specific lot.

Risk

The discrepancy between 'mg' and 'Units' on the medication label can lead to significant dosing errors. If a healthcare provider administers the drug based on the incorrect concentration listed on the label, the patient may receive an improper dose of Heparin, potentially leading to ineffective treatment or adverse health consequences.

What You Should Do

  1. Identify the affected product by checking the label for HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution with NDC 42852-725-65.
  2. Check for the specific Lot number 12/19/18 0242 72565S and a Beyond Use Date (BUD) of 3/31/19.
  3. Immediately stop using any syringes matching this description and isolate them to prevent further use.
  4. Contact your healthcare provider or pharmacist for guidance if you have been administered this medication or if you have questions about your treatment.
  5. Contact Advanced Pharma Inc. (Avella of Houston) at (877) 794-0404 to arrange for the return of any unused product and to receive instructions for a refund.
  6. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Return for refund and contact healthcare provider.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact Advanced Pharma Inc. (Avella of Houston) at (877) 794-0404 for further instructions.

Affected Products

Product: HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution (50 mL)
Model:
NDC: 42852-725-65
Lot Numbers:
12/19/18 0242 72565S (BUD: 3/31/19)
Date Ranges: BUD: 3/31/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81941
Status: Resolved
Manufacturer: Advanced Pharma Inc.
Sold By: Avella of Houston
Manufactured In: United States
Units Affected: 160 syringes
Distributed To: Texas, Washington
Agency Last Updated: February 8, 2019

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.