Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals: Heparin Sodium Injection Recalled for Preservative Mislabeling and Contamination

Agency Publication Date: August 24, 2020

Summary

SCA Pharmaceuticals is recalling 3,352 containers of various Heparin Sodium injections because they were found to be cross-contaminated with benzyl alcohol. These products, which are used as blood thinners in hospital settings, were incorrectly labeled as containing methylparaben and propylparaben as preservatives, but they actually contained undeclared benzyl alcohol and no parabens at all. This recall affects four different dosage and size configurations of Heparin Sodium in 0.9% Sodium Chloride, which were distributed nationwide within the United States.

Risk

The presence of undeclared benzyl alcohol poses a serious risk of toxicity, especially in certain patient populations such as neonates and infants, who may experience a 'gasping syndrome' from exposure. Additionally, patients with known sensitivities or allergies to benzyl alcohol may suffer severe adverse reactions.

What You Should Do

Check your medical supplies for Heparin Sodium 2,500 units in 0.9% Sodium Chloride (500 mL) with NDC 70004-0655-44 and lot numbers 1220019269, 1220019278 (Exp 08/21/2020), or 1220019386 (Exp 08/25/2020).
Check for Heparin Sodium 5,000 units in 0.9% Sodium Chloride (500 mL) with NDC 70004-0650-44 and lot number 1220019289 (Exp 08/21/2020).
Check for Heparin Sodium 5,000 units in 0.9% Sodium Chloride (1,000 mL) with NDC 70004-0650-46 and lot numbers 1220019243 (Exp 08/20/2020), 1220019439, 1220019279, 1220019392 (Exp 08/24/2020), or 1220019488 (Exp 08/26/2020).
Check for Heparin Sodium 10,000 units in 0.9% Sodium Chloride (1,000 mL) with NDC 70004-0652-46 and lot number 1220019457 (Exp 08/24/2020).
Immediately stop using the affected products and contact your healthcare provider or pharmacist for guidance on alternative treatments.
Return any unused containers to the place of purchase or pharmacy for a refund and contact SCA Pharmaceuticals for further return instructions.
If you have questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall return and refund process.

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 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL)

Model:

NDC#: 70004-0655-44

Recall #: D-1550-2020

UPC Codes:

70004065544

Lot Numbers:

1220019269 (Exp 08/21/2020)

1220019278 (Exp 08/21/2020)

1220019386 (Exp 08/25/2020)

Product: Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL)

Model:

NDC#: 70004-0650-44

Recall #: D-1551-2020

UPC Codes:

70004065044

Lot Numbers:

1220019289 (Exp 08/21/2020)

Product: Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL)

Model:

NDC#: 70004-0650-46

Recall #: D-1552-2020

UPC Codes:

70004065046

Lot Numbers:

1220019243 (Exp 08/20/2020)

1220019439 (Exp 08/24/2020)

1220019279 (Exp 08/24/2020)

1220019392 (Exp 08/24/2020)

1220019488 (Exp 08/26/2020)

Product: Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL)

Model:

NDC#: 70004-0652-46

Recall #: D-1553-2020

UPC Codes:

70004065246

Lot Numbers:

1220019457 (Exp 08/24/2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86193

Status: Resolved

Manufacturer: SCA Pharmaceuticals

Sold By: Hospitals; Medical clinics; Healthcare facilities

Manufactured In: United States

Units Affected: 4 products (1,097 Containers; 366 Containers; 1,527 Containers; 362 Containers)

Distributed To: Nationwide

Agency Last Updated: August 27, 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 · 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.

Summary

Risk

What You Should Do

Check your medical supplies for Heparin Sodium 2,500 units in 0.9% Sodium Chloride (500 mL) with NDC 70004-0655-44 and lot numbers 1220019269, 1220019278 (Exp 08/21/2020), or 1220019386 (Exp 08/25/2020).

Check for Heparin Sodium 5,000 units in 0.9% Sodium Chloride (500 mL) with NDC 70004-0650-44 and lot number 1220019289 (Exp 08/21/2020).

Check for Heparin Sodium 5,000 units in 0.9% Sodium Chloride (1,000 mL) with NDC 70004-0650-46 and lot numbers 1220019243 (Exp 08/20/2020), 1220019439, 1220019279, 1220019392 (Exp 08/24/2020), or 1220019488 (Exp 08/26/2020).

Check for Heparin Sodium 10,000 units in 0.9% Sodium Chloride (1,000 mL) with NDC 70004-0652-46 and lot number 1220019457 (Exp 08/24/2020).

Immediately stop using the affected products and contact your healthcare provider or pharmacist for guidance on alternative treatments.

Return any unused containers to the place of purchase or pharmacy for a refund and contact SCA Pharmaceuticals for further return instructions.

If you have questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL)

Model:

NDC#: 70004-0655-44

Recall #: D-1550-2020

UPC Codes:

70004065544

Lot Numbers:

1220019269 (Exp 08/21/2020)

1220019278 (Exp 08/21/2020)

1220019386 (Exp 08/25/2020)

Product: Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL)

Model:

NDC#: 70004-0650-44

Recall #: D-1551-2020

UPC Codes:

70004065044

Lot Numbers:

1220019289 (Exp 08/21/2020)

Product: Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL)

Model:

NDC#: 70004-0650-46

Recall #: D-1552-2020

UPC Codes:

70004065046

Lot Numbers:

1220019243 (Exp 08/20/2020)

1220019439 (Exp 08/24/2020)

1220019279 (Exp 08/24/2020)

1220019392 (Exp 08/24/2020)

1220019488 (Exp 08/26/2020)

Product: Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL)

Model:

NDC#: 70004-0652-46

Recall #: D-1553-2020

UPC Codes:

70004065246

Lot Numbers:

1220019457 (Exp 08/24/2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86193

Status: Resolved

Manufacturer: SCA Pharmaceuticals

Sold By: Hospitals; Medical clinics; Healthcare facilities

Manufactured In: United States

Units Affected: 4 products (1,097 Containers; 366 Containers; 1,527 Containers; 362 Containers)

Distributed To: Nationwide

Agency Last Updated: August 27, 2020