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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals: Heparin Sodium Injection Recalled for Subpotency

Agency Publication Date: June 17, 2020
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Summary

SCA Pharmaceuticals is recalling approximately 333 bags of Heparin Sodium (5,000 units in 0.9% Sodium Chloride 1000 mL bag). This prescription medication is being recalled because testing discovered the drug was subpotent, meaning it was not at the required strength at its 30-day stability checkpoint. The affected products were distributed specifically to hospitals in California and Pennsylvania.

Risk

A subpotent drug may not provide the intended therapeutic effect, which for a blood thinner like Heparin, could lead to inadequate anticoagulation and a failure to prevent or treat blood clots.

What You Should Do

  1. Identify if you have the affected Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bags (5 units/mL) by checking the label for NDC 70004-0650-46.
  2. Check the packaging for Lot #: 1220017764 with an expiration date of June 24, 2020.
  3. Contact your healthcare provider or pharmacist immediately if you believe you have received this medication or if you have questions regarding your treatment.
  4. Return any unused product to the pharmacy or hospital where it was received to obtain a refund.
  5. Contact SCA Pharmaceuticals at their Windsor, CT location or through the distributor at 755 Rainbow Rd Ste B, Windsor, CT 06095-1024 for further instructions.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall guidance for subpotent medication

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Heparin Sodium 5,000 units in 0.9% Sodium Chloride (1000 mL bag)
Model:
NDC 70004-0650-46
Recall #: D-1311-2020
Lot Numbers:
1220017764 (Exp. June 24, 2020)
Date Ranges: June 24, 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85865
Status: Resolved
Manufacturer: SCA Pharmaceuticals
Sold By: Hospitals
Manufactured In: United States
Units Affected: 333 bags
Distributed To: California, Pennsylvania
Agency Last Updated: August 12, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.