Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals, Inc.: Furosemide Injection Recalled for Visible Precipitate

Agency Publication Date: September 7, 2018

Summary

SCA Pharmaceuticals is recalling approximately 1,384 bags of Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection. This voluntary recall was initiated after a customer reported seeing visible solids (precipitate) in the solution, which is believed to be the active drug ingredient, Furosemide, coming out of the liquid. The affected products were distributed to three hospitals in Washington D.C., Virginia, and Connecticut in 2018. Consumers should contact their healthcare provider if they have received this medication.

Risk

Injecting a solution containing visible particles can cause serious health risks, including the formation of blood clots that could travel to the lungs or other organs, and inflammatory reactions. Additionally, if the active ingredient has formed solids, the patient may not receive the full intended dose of the medication.

What You Should Do

Identify the affected product: Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection in a 100 mL Single Dose Container bag with barcode 70004063032.
Check for the following affected lot numbers and Beyond Use Dates (BUD): Lot 20180711@18 (BUD 10/3/2018), 20180712@19 (BUD 10/4/2018), 20180712@21 (BUD 10/4/2018), 20180712@24 (BUD 10/4/2018), 20180713@19 (BUD 10/5/2018), 20180727@21 (BUD 10/19/2018), and 20180803@20 (BUD 10/26/2018).
Stop using the product immediately if it matches any of the lot numbers and dates listed above.
Contact your healthcare provider or pharmacist for guidance and to report any adverse health effects.
Return any unused bags to the place of purchase or the hospital pharmacy for a refund and contact SCA Pharmaceuticals at 877-550-5059 for instructions on product return.
For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider or pharmacist and return unused product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer at 877-550-5059.

Affected Products

Product: Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection (100 mL Single Dose Container bag)

Model:

D-1189-2018

UPC Codes:

70004063032

Lot Numbers:

20180711@18 (BUD: 10/3/2018)

20180712@19 (BUD: 10/4/2018)

20180712@21 (BUD: 10/4/2018)

20180712@24 (BUD: 10/4/2018)

20180713@19 (BUD: 10/5/2018)

20180727@21 (BUD: 10/19/2018)

20180803@20 (BUD: 10/26/2018)

Date Ranges: October 3, 2018 - October 26, 2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80915

Status: Resolved

Manufacturer: SCA Pharmaceuticals, Inc.

Sold By: Hospitals in Washington D.C.; Hospitals in Virginia; Hospitals in Connecticut

Manufactured In: United States

Units Affected: 1384 bags

Distributed To: District of Columbia, Virginia, Connecticut

Agency Last Updated: September 12, 2018

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

Identify the affected product: Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection in a 100 mL Single Dose Container bag with barcode 70004063032.

Check for the following affected lot numbers and Beyond Use Dates (BUD): Lot 20180711@18 (BUD 10/3/2018), 20180712@19 (BUD 10/4/2018), 20180712@21 (BUD 10/4/2018), 20180712@24 (BUD 10/4/2018), 20180713@19 (BUD 10/5/2018), 20180727@21 (BUD 10/19/2018), and 20180803@20 (BUD 10/26/2018).

Stop using the product immediately if it matches any of the lot numbers and dates listed above.

Contact your healthcare provider or pharmacist for guidance and to report any adverse health effects.

Return any unused bags to the place of purchase or the hospital pharmacy for a refund and contact SCA Pharmaceuticals at 877-550-5059 for instructions on product return.

For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection (100 mL Single Dose Container bag)

Model:

D-1189-2018

UPC Codes:

70004063032

Lot Numbers:

20180711@18 (BUD: 10/3/2018)

20180712@19 (BUD: 10/4/2018)

20180712@21 (BUD: 10/4/2018)

20180712@24 (BUD: 10/4/2018)

20180713@19 (BUD: 10/5/2018)

20180727@21 (BUD: 10/19/2018)

20180803@20 (BUD: 10/26/2018)

Date Ranges: October 3, 2018 - October 26, 2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80915

Status: Resolved

Manufacturer: SCA Pharmaceuticals, Inc.

Sold By: Hospitals in Washington D.C.; Hospitals in Virginia; Hospitals in Connecticut

Manufactured In: United States

Units Affected: 1384 bags

Distributed To: District of Columbia, Virginia, Connecticut

Agency Last Updated: September 12, 2018