Medications & Supplements/Prescription Drugs

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center: Amino Acid and Cardioplegia Solutions Recalled for Sterility and Leak Risks

Agency Publication Date: October 18, 2019

Summary

Nephron Pharmaceuticals is recalling 1,209 bags of Amino Acid Injection (50 g/1000 mL) and del Nido Cardioplegia Solution (1000 mL) because the intravenous bags may leak. A leak in the bag compromises the sterile seal of the medication, which is critical for patient safety during administration. This recall affects various lots distributed nationwide with expiration dates in October and November 2019. Healthcare providers and pharmacies should immediately stop using these products and contact the manufacturer for further instructions.

Risk

The potential for the intravenous bags to leak means the medication inside is no longer guaranteed to be sterile. Using non-sterile medical solutions directly in the bloodstream or during surgical procedures poses a serious risk of life-threatening infections and other medical complications.

What You Should Do

Check your medical supply inventory for Amino Acid Injection 50 g/1000 mL (NDC 69374-988-10) with lot numbers AA9023A (Exp. 10/24/2019) or AA9023B (Exp. 10/24/2019).
Check for del Nido Cardioplegia Solution 1000 mL (NDC 69374-984-10) with lot numbers NC9048A (Exp. 10/14/2019), NC9048B (Exp. 10/14/2019), NC9049A (Exp. 10/16/2019), NC9049B (Exp. 10/16/2019), NC9051A (Exp. 10/21/2019), NC9051B (Exp. 10/21/2019), NC9052A (Exp. 10/22/2019), NC9052B (Exp. 10/22/2019), NC9053A (Exp. 10/23/2019), NC9053B (Exp. 10/23/2019), NC9054A (Exp. 10/28/2019), NC9054B (Exp. 10/28/2019), NC9055A (Exp. 10/30/2019), or NC9056B (Exp. 11/04/2019).
Immediately stop using any affected products and isolate them to prevent accidental use in a clinical setting.
Contact your healthcare provider or pharmacist for guidance if you have any questions or have been administered these products.
Return any unused product to the place of purchase for a refund and contact Nephron Pharmaceuticals at 1-888-723-3332 for specific return and disposal instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider contact and product return.

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

Affected Products

Product: Amino Acid Injection 50 g/1000 mL (50 mg/mL)

Model:

69374-988-10

Lot Numbers:

AA9023A (Exp. 10/24/2019)

AA9023B (Exp. 10/24/2019)

Date Ranges: Exp. 10/24/2019

Product: del Nido Cardioplegia Solution (1000 mL)

Model:

69374-984-10

Lot Numbers:

NC9048A (Exp. 10/14/2019)

NC9048B (Exp. 10/14/2019)

NC9049A (Exp. 10/16/2019)

NC9049B (Exp. 10/16/2019)

NC9051A (Exp. 10/21/2019)

NC9051B (Exp. 10/21/2019)

NC9052A (Exp. 10/22/2019)

NC9052B (Exp. 10/22/2019)

NC9053A (Exp. 10/23/2019)

NC9053B (Exp. 10/23/2019)

NC9054A (Exp. 10/28/2019)

NC9054B (Exp. 10/28/2019)

NC9055A (Exp. 10/30/2019)

NC9056B (Exp. 11/04/2019)

Date Ranges: 10/14/2019 - 11/04/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83999

Status: Resolved

Manufacturer: Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

Sold By: Hospitals; Medical facilities; Pharmacies

Manufactured In: United States

Units Affected: 2 products (162 bags; 1047 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.

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

What You Should Do

Check your medical supply inventory for Amino Acid Injection 50 g/1000 mL (NDC 69374-988-10) with lot numbers AA9023A (Exp. 10/24/2019) or AA9023B (Exp. 10/24/2019).

Check for del Nido Cardioplegia Solution 1000 mL (NDC 69374-984-10) with lot numbers NC9048A (Exp. 10/14/2019), NC9048B (Exp. 10/14/2019), NC9049A (Exp. 10/16/2019), NC9049B (Exp. 10/16/2019), NC9051A (Exp. 10/21/2019), NC9051B (Exp. 10/21/2019), NC9052A (Exp. 10/22/2019), NC9052B (Exp. 10/22/2019), NC9053A (Exp. 10/23/2019), NC9053B (Exp. 10/23/2019), NC9054A (Exp. 10/28/2019), NC9054B (Exp. 10/28/2019), NC9055A (Exp. 10/30/2019), or NC9056B (Exp. 11/04/2019).

Immediately stop using any affected products and isolate them to prevent accidental use in a clinical setting.

Contact your healthcare provider or pharmacist for guidance if you have any questions or have been administered these products.

Return any unused product to the place of purchase for a refund and contact Nephron Pharmaceuticals at 1-888-723-3332 for specific return and disposal instructions.

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

Affected Products

Product: Amino Acid Injection 50 g/1000 mL (50 mg/mL)

Model:

69374-988-10

Lot Numbers:

AA9023A (Exp. 10/24/2019)

AA9023B (Exp. 10/24/2019)

Date Ranges: Exp. 10/24/2019

Product: del Nido Cardioplegia Solution (1000 mL)

Model:

69374-984-10

Lot Numbers:

NC9048A (Exp. 10/14/2019)

NC9048B (Exp. 10/14/2019)

NC9049A (Exp. 10/16/2019)

NC9049B (Exp. 10/16/2019)

NC9051A (Exp. 10/21/2019)

NC9051B (Exp. 10/21/2019)

NC9052A (Exp. 10/22/2019)

NC9052B (Exp. 10/22/2019)

NC9053A (Exp. 10/23/2019)

NC9053B (Exp. 10/23/2019)

NC9054A (Exp. 10/28/2019)

NC9054B (Exp. 10/28/2019)

NC9055A (Exp. 10/30/2019)

NC9056B (Exp. 11/04/2019)

Date Ranges: 10/14/2019 - 11/04/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83999

Status: Resolved

Manufacturer: Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

Sold By: Hospitals; Medical facilities; Pharmacies

Manufactured In: United States

Units Affected: 2 products (162 bags; 1047 bags)

Distributed To: Nationwide