Advanced Pharma Inc. recalls HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Ster…

Recall date

January 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0430-2019

FDA classification

Class II

Brand / firm

Advanced Pharma Inc.

Sold / distributed

TX, WA

Why it was 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)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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