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
Reported: August 19, 2020 Initiated: July 29, 2020 #D-1495-2020
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
Reason for Recall
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Details
- Recalling Firm
- SCA Pharmaceuticals
- Units Affected
- 3,932 bags
- Distribution
- Product was distributed nationwide within the United States.
- Location
- Windsor, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SCA Pharmaceuticals. Units affected: 3,932 bags.
Why was this product recalled? ▼
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 19, 2020. Severity: Moderate. Recall number: D-1495-2020.
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