Recalls / Class II
Class IID-0430-2019
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
- Affected lot / code info
- Lot: 12/19/18 0242 72565S BUD: 3/31/19
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)
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, N/A, Houston, Texas 77054-2520
Distribution
- Quantity
- 160 syringes
- Distribution pattern
- TX, WA
Timeline
- Recall initiated
- 2019-01-15
- FDA classified
- 2019-02-08
- Posted by FDA
- 2019-01-30
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0430-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.