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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals: Heparin Sodium Bags Recalled for Subpotent Potency Results

Agency Publication Date: August 12, 2020
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Summary

SCA Pharmaceuticals is recalling 3,932 bags of Heparin Sodium 5,000 units in 0.9% Sodium Chloride (5 units/mL) due to test results showing the drug is subpotent. This prescription medication, used to prevent blood clots, was found to have out-of-specification potency levels during a 30-day stability check. The affected 1000 mL bags were distributed nationwide to healthcare facilities. Consumers should contact their healthcare provider or pharmacist immediately, as a subpotent drug may not provide the intended therapeutic effect.

Risk

If the Heparin Sodium solution is subpotent, it may fail to effectively prevent or treat blood clots, potentially leading to serious thromboembolic events such as deep vein thrombosis or pulmonary embolism.

What You Should Do

  1. Check your supply for Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bags with NDC 70004-0650-46.
  2. Verify if your product matches one of the following affected lot numbers and expiration dates: Lot 1220018755 (Exp. 7/30/2020); Lots 1220018861 or 1220018850 (Exp. 8/4/2020); Lot 1220018899 (Exp. 8/5/2020); Lot 1220019027 (Exp. 8/11/2020); Lot 1220019075 (Exp. 8/12/2020); Lot 1220019243 (Exp. 8/20/2020); Lots 1220019439, 1220019279, or 1220019392 (Exp. 8/24/2020); or Lot 1220019488 (Exp. 8/26/2020).
  3. Immediately stop using any product from the affected lots and contact your healthcare provider or pharmacist for guidance regarding alternative treatments.
  4. Return any unused product to the pharmacy or place of purchase for a refund and contact SCA Pharmaceuticals at 755 Rainbow Rd. Windsor, CT 06095 for further instructions.
  5. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Refund for subpotent drug product

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 (5 units/mL)
Model:
NDC 70004-0650-46
Lot Numbers:
1220018755 (Exp. 7/30/2020)
1220018861 (Exp. 8/4/2020)
1220018850 (Exp. 8/4/2020)
1220018899 (Exp. 8/5/2020)
1220019027 (Exp. 8/11/2020)
1220019075 (Exp. 8/12/2020)
1220019243 (Exp. 8/20/2020)
1220019439 (Exp. 8/24/2020)
1220019279 (Exp. 8/24/2020)
1220019392 (Exp. 8/24/2020)
1220019488 (Exp. 8/26/2020)
Date Ranges: Exp. Date 7/30/2020, Exp. Date 8/4/2020, Exp. Date 8/5/2020, Exp. Date 8/11/2020, Exp. Date 8/12/2020, Exp. Date 8/20/2020, Exp. Date 8/24/2020, Exp. Date 8/26/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86194
Status: Resolved
Manufacturer: SCA Pharmaceuticals
Sold By: Hospitals; Healthcare facilities
Manufactured In: United States
Units Affected: 3,932 bags
Distributed To: Nationwide

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.

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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 · 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.