Class II
Terminated
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
- Company
- Advanced Pharma Inc.
- Recall Initiated
- January 15, 2019
- Posted
- January 30, 2019
- Recall Number
- D-0430-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 160 syringes
- Firm Location
- Houston, TX, United States
Reason for Recall
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)
Distribution
TX, WA
Lot / Code Info
Lot: 12/19/18 0242 72565S BUD: 3/31/19
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