Reported Jan 30, 2019 · Terminated
HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL,…
Advanced Pharma Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Pharma Inc. · 9265 Kirby Dr · Houston, TX · 77054-2520
Is this the product you have?
- 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 ---- NDC42852-725-65
- Lot codes and dates
- Lot12/19/18 0242 72565S
- BUD3/31/19
- Amount recalled
- 160 syringes
Where it was sold
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)
This product could cause temporary or reversible health problems — stop using it.
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