Why it was recalled
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Product description
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
Lot numbers, UPCs & expiration codes
Lot #: 1220017764, exp. date June 24, 2020
Where it was sold
Product was distributed to hospitals in PA and CA.
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-1311-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 16, 2020
- FDA report date
- Jun 24, 2020
- Quantity
- 333 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1311-2020, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 85865
- Address
- 755 Rainbow Rd Ste B
- Code information
- Lot #: 1220017764, exp. date June 24, 2020
- Postal code
- 06095-1024
- Report date
- Jun 24, 2020
- Product type
- Drugs
- Recall number
- D-1311-2020
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 333 bags
- Termination date
- Mar 17, 2021
- Reason for recall
- Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
- Distribution pattern
- Product was distributed to hospitals in PA and CA.
- Recall initiation date
- Jun 16, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 17, 2020