Drug product
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
D-0430-2019
Product summary
- Event
- Event 81941
- Status
- Terminated
- Classification
- Class II
- Quantity
- 160 syringes
- Official record key
drug-enforcement:D-0430-2019
Official wording
Reason: 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)
Code information: Lot: 12/19/18 0242 72565S BUD: 3/31/19
Distribution pattern: TX, WA
Derived failure modes
-
Labeling or packaging
Labeling; Label Error