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)
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 12/19/18 0242 72565S BUD: 3/31/19
Where it was sold
TX, WA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0430-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 15, 2019
- FDA report date
- Jan 30, 2019
- Quantity
- 160 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0430-2019, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 81941
- Address
- 9265 Kirby Dr
- Code information
- Lot: 12/19/18 0242 72565S BUD: 3/31/19
- Postal code
- 77054-2520
- Report date
- Jan 30, 2019
- Product type
- Drugs
- Recall number
- D-0430-2019
- Classification
- Class II
- Recalling firm
- Advanced Pharma Inc.
- Product quantity
- 160 syringes
- Termination date
- May 1, 2019
- 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)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- TX, WA
- Recall initiation date
- Jan 15, 2019
- Initial firm notification
- Telephone
- Center classification date
- Feb 8, 2019