Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution Recalled by Advanced Pharma Inc. Due to Labeling; Label Error on Declared Strength; label incorrectly...

Date: January 15, 2019
Company: Advanced Pharma Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Advanced Pharma Inc. directly.

Affected Products

HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe, Avella of Houston an FDA Registered 503B Outsourcing Facility 9265 Kirby Dr. Houston, TX 77054 (877) 794-0404 ---- NDC: 42852-725-65

Quantity: 160 syringes

Why Was This Recalled?

Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)

Where Was This Sold?

This product was distributed to 2 states: TX, WA

Affected (2 states)Not affected

About Advanced Pharma Inc.

Advanced Pharma Inc. has 99 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report