Medications & Supplements/Prescription Drugs

AuroMedics Pharma LLC: Various IV Injection Bags Recalled for Potential Lack of Sterility and Mold

Agency Publication Date: May 3, 2018

Summary

AuroMedics Pharma LLC has recalled approximately 1,576,049 bags of Linezolid, Levofloxacin, and Levetiracetam intravenous injections because of reports of leaking bags and mold found between the product bag and its overwrap. This defect compromises the sterility of the medication, which is critical for products injected directly into the bloodstream. These products were distributed nationwide in the United States to hospitals and healthcare facilities.

Risk

The presence of mold and compromised bag integrity means the medication may not be sterile. Injecting a non-sterile drug into a patient can lead to serious, life-threatening systemic infections.

What You Should Do

Check your medical supplies for the following NDC numbers: Linezolid (55150-242-51), Levofloxacin (55150-243-46, 55150-244-47, 55150-245-52), and Levetiracetam (55150-246-47, 55150-247-47, 55150-248-47).
Verify the lot numbers and expiration dates on the packaging. For Linezolid, check for lots such as CLZ160001 through CLZ170017 with expirations ranging from July 2018 to October 2019. For Levofloxacin, check for lots beginning with 'CLF' and for Levetiracetam, check for lots beginning with 'CLV' as detailed in the affected products list.
Immediately stop using and quarantine any products from the affected lot numbers to prevent administration to patients.
Contact your healthcare provider or pharmacist if you have concerns regarding medication you have already received.
Return any unused product to the pharmacy or place of purchase for a refund and contact AuroMedics Pharma LLC for specific return instructions.
For additional questions or to report a problem, 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

Full refund for returned unused injection bags.

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

Affected Products

Product: Linezolid Injection 600 mg per 300 mL (2 mg/mL)

Model:

NDC 55150-242-51

Lot Numbers:

CLZ160001 (Exp July 2018)

CLZ160002 (Exp July 2018)

CLZ160003 (Exp July 2018)

CLZ160004 (Exp July 2018)

CLZ160005 (Exp August 2018)

CLZ160006 (Exp August 2018)

CLZ160008 (Exp August 2018)

CLZ160009 (Exp August 2018)

CLZ160010 (Exp August 2018)

CLZ160012 (Exp August 2018)

CLZ160013 (Exp October 2018)

CLZ160014 (Exp October 2018)

CLZ160015 (Exp October 2018)

CLZ160016 (Exp October 2018)

CLZ160017 (Exp November 2018)

CLZ160018 (Exp November 2018)

CLZ160019 (Exp November 2018)

CLZ160021 (Exp November 2018)

CLZ160022 (Exp November 2018)

CLZ160023 (Exp November 2018)

CLZ170001 (Exp March 2019)

CLZ170002 (Exp March 2019)

CLZ170003 (Exp March 2019)

CLZ170004 (Exp March 2019)

CLZ170005 (Exp March 2019)

CLZ170006 (Exp March 2019)

CLZ170007 (Exp May 2019)

CLZ170008 (Exp May 2019)

CLZ170009 (Exp May 2019)

CLZ170010 (Exp May 2019)

CLZ170011 (Exp June 2019)

CLZ170012 (Exp June 2019)

CLZ170013 (Exp September 2019)

CLZ170014 (Exp September 2019)

CLZ170015 (Exp September 2019)

CLZ170016 (Exp September 2019)

CLZ170017 (Exp October 2019)

Product: Levofloxacin in 5% Dextrose Injection, 250 mg (5 mg/mL) in 50 mL

Model:

NDC 55150-243-46

Lot Numbers:

CLF160002 (Exp May 2018)

CLF160004 (Exp May 2018)

CLF160005 (Exp May 2018)

CLF160006 (Exp June 2018)

CLF160007 (Exp June 2018)

CLF170027 (Exp July 2019)

CLF170029 (Exp August 2019)

Product: Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL)

Model:

NDC 55150-246-47

Lot Numbers:

CLV160016 (Exp Sept 2018)

CLV160017 (Exp Sept 2018)

CLV160018 (Exp Sept 2018)

CLV160019 (Exp Oct 2018)

CLV160020 (Exp Nov 2018)

CLV160021 (Exp Nov 2018)

CLV160031 (Exp Nov 2018)

CLV160032 (Exp 12/18)

CLV170001 (Exp 12/18)

CLV170008 (Exp April 2019)

CLV170009 (Exp April 2019)

CLV170020 (Exp Oct 2019)

CLV170021 (Exp Oct 2019)

CLV170022 (Exp Oct 2019)

Product: Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL)

Model:

NDC 55150-247-47

Lot Numbers:

CLV160013 (Exp Sept 2018)

CLV160014 (Exp Sept 2018)

CLV160015 (Exp Sept 2018)

CLV160022 (Exp Oct 2018)

CLV160023 (Exp Oct 2018)

CLV160024 (Exp Oct 2018)

CLV160025 (Exp Oct 2018)

CLV160026 (Exp Oct 2018)

CLV160027 (Exp Oct 2018)

CLV160028 (Exp Oct 2018)

CLV160029 (Exp Oct 2018)

CLV160030 (Exp Oct 2018)

CLV170002 (Exp Dec 2018)

CLV170010 (Exp April 2019)

CLV170027 (Exp Oct 2019)

CLV170028 (Exp Oct 2019)

CLV170029 (Exp Oct 2019)

CLV170030 (Exp Oct 2019)

Product: Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL)

Model:

NDC 55150-248-47

Lot Numbers:

CLV160004 (Exp September 2018)

CLV160005 (Exp September 2018)

CLV160006 (Exp September 2018)

CLV170011 (Exp June 2019)

CLV170015 (Exp June 2019)

CLV170016 (Exp June 2019)

Product: Levofloxacin in 5% Dextrose Injection, 500 mg (5 mg/mL) in 100 mL

Model:

NDC 55150-244-47

Lot Numbers:

CLF160008 (Exp June 2018)

CLF160009 (Exp June 2018)

CLF160010 (Exp June 2018)

CLF160011 (Exp June 2018)

CLF160015 (Exp August 2018)

CLF160016 (Exp August 2018)

CLF160017 (Exp August 2018)

CLF170001 (Exp December 2018)

CLF170023 (Exp May 2019)

CLF170024 (Exp May 2019)

CLF170039 (Exp August 2019)

CLF170040 (Exp August 2019)

CLF170041 (Exp August 2019)

CLF170042 (Exp August 2019)

CLF170043 (Exp August 2019)

CLF170044 (Exp August 2019)

CLF170045 (Exp August 2019)

CLF170046 (Exp August 2019)

CLF170047 (Exp August 2019)

Product: Levofloxacin in 5% Dextrose Injection, 750 mg (5 mg/mL) in 150 mL

Model:

NDC 55150-245-52

Lot Numbers:

CLF160012 (Exp July 2018)

CLF160014 (Exp July 2018)

CLF170007 (Exp February 2019)

CLF170008 (Exp February 2019)

CLF170009 (Exp February 2019)

CLF170010 (Exp February 2019)

CLF170011 (Exp February 2019)

CLF170012 (Exp February 2019)

CLF170013 (Exp February 2019)

CLF170014 (Exp March 2019)

CLF170015 (Exp March 2019)

CLF170016 (Exp March 2019)

CLF170017 (Exp April 2019)

CLF170018 (Exp April 2019)

CLF170019 (Exp April 2019)

CLF170020 (Exp May 2019)

CLF170021 (Exp May 2019)

CLF170022 (Exp May 2019)

CLF170035 (Exp August 2019)

CLF170036 (Exp August 2019)

CLF170037 (Exp August 2019)

CLF170038 (Exp August 2019)

CLF170048 (Exp September 2019)

CLF170049 (Exp September 2019)

CLF170050 (Exp September 2019)

CLF170051 (Exp September 2019)

CLF170052 (Exp September 2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79772

Status: Resolved

Manufacturer: AuroMedics Pharma LLC

Sold By: Hospitals; Healthcare Facilities

Manufactured In: India, United States

Units Affected: 7 products (395150 bags; 46824 bags; 261250 bags; 188941 bags; 67300 bags; 308472 bags; 308112 bags)

Distributed To: Nationwide

Agency Last Updated: February 4, 2019

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 supplies for the following NDC numbers: Linezolid (55150-242-51), Levofloxacin (55150-243-46, 55150-244-47, 55150-245-52), and Levetiracetam (55150-246-47, 55150-247-47, 55150-248-47).

Verify the lot numbers and expiration dates on the packaging. For Linezolid, check for lots such as CLZ160001 through CLZ170017 with expirations ranging from July 2018 to October 2019. For Levofloxacin, check for lots beginning with 'CLF' and for Levetiracetam, check for lots beginning with 'CLV' as detailed in the affected products list.

Immediately stop using and quarantine any products from the affected lot numbers to prevent administration to patients.

Contact your healthcare provider or pharmacist if you have concerns regarding medication you have already received.

Return any unused product to the pharmacy or place of purchase for a refund and contact AuroMedics Pharma LLC for specific return instructions.

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

Affected Products

Product: Linezolid Injection 600 mg per 300 mL (2 mg/mL)

Model:

NDC 55150-242-51

Lot Numbers:

CLZ160001 (Exp July 2018)

CLZ160002 (Exp July 2018)

CLZ160003 (Exp July 2018)

CLZ160004 (Exp July 2018)

CLZ160005 (Exp August 2018)

CLZ160006 (Exp August 2018)

CLZ160008 (Exp August 2018)

CLZ160009 (Exp August 2018)

CLZ160010 (Exp August 2018)

CLZ160012 (Exp August 2018)

CLZ160013 (Exp October 2018)

CLZ160014 (Exp October 2018)

CLZ160015 (Exp October 2018)

CLZ160016 (Exp October 2018)

CLZ160017 (Exp November 2018)

CLZ160018 (Exp November 2018)

CLZ160019 (Exp November 2018)

CLZ160021 (Exp November 2018)

CLZ160022 (Exp November 2018)

CLZ160023 (Exp November 2018)

CLZ170001 (Exp March 2019)

CLZ170002 (Exp March 2019)

CLZ170003 (Exp March 2019)

CLZ170004 (Exp March 2019)

CLZ170005 (Exp March 2019)

CLZ170006 (Exp March 2019)

CLZ170007 (Exp May 2019)

CLZ170008 (Exp May 2019)

CLZ170009 (Exp May 2019)

CLZ170010 (Exp May 2019)

CLZ170011 (Exp June 2019)

CLZ170012 (Exp June 2019)

CLZ170013 (Exp September 2019)

CLZ170014 (Exp September 2019)

CLZ170015 (Exp September 2019)

CLZ170016 (Exp September 2019)

CLZ170017 (Exp October 2019)

Product: Levofloxacin in 5% Dextrose Injection, 250 mg (5 mg/mL) in 50 mL

Model:

NDC 55150-243-46

Lot Numbers:

CLF160002 (Exp May 2018)

CLF160004 (Exp May 2018)

CLF160005 (Exp May 2018)

CLF160006 (Exp June 2018)

CLF160007 (Exp June 2018)

CLF170027 (Exp July 2019)

CLF170029 (Exp August 2019)

Product: Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL)

Model:

NDC 55150-246-47

Lot Numbers:

CLV160016 (Exp Sept 2018)

CLV160017 (Exp Sept 2018)

CLV160018 (Exp Sept 2018)

CLV160019 (Exp Oct 2018)

CLV160020 (Exp Nov 2018)

CLV160021 (Exp Nov 2018)

CLV160031 (Exp Nov 2018)

CLV160032 (Exp 12/18)

CLV170001 (Exp 12/18)

CLV170008 (Exp April 2019)

CLV170009 (Exp April 2019)

CLV170020 (Exp Oct 2019)

CLV170021 (Exp Oct 2019)

CLV170022 (Exp Oct 2019)

Product: Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL)

Model:

NDC 55150-247-47

Lot Numbers:

CLV160013 (Exp Sept 2018)

CLV160014 (Exp Sept 2018)

CLV160015 (Exp Sept 2018)

CLV160022 (Exp Oct 2018)

CLV160023 (Exp Oct 2018)

CLV160024 (Exp Oct 2018)

CLV160025 (Exp Oct 2018)

CLV160026 (Exp Oct 2018)

CLV160027 (Exp Oct 2018)

CLV160028 (Exp Oct 2018)

CLV160029 (Exp Oct 2018)

CLV160030 (Exp Oct 2018)

CLV170002 (Exp Dec 2018)

CLV170010 (Exp April 2019)

CLV170027 (Exp Oct 2019)

CLV170028 (Exp Oct 2019)

CLV170029 (Exp Oct 2019)

CLV170030 (Exp Oct 2019)

Product: Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL)

Model:

NDC 55150-248-47

Lot Numbers:

CLV160004 (Exp September 2018)

CLV160005 (Exp September 2018)

CLV160006 (Exp September 2018)

CLV170011 (Exp June 2019)

CLV170015 (Exp June 2019)

CLV170016 (Exp June 2019)

Product: Levofloxacin in 5% Dextrose Injection, 500 mg (5 mg/mL) in 100 mL

Model:

NDC 55150-244-47

Lot Numbers:

CLF160008 (Exp June 2018)

CLF160009 (Exp June 2018)

CLF160010 (Exp June 2018)

CLF160011 (Exp June 2018)

CLF160015 (Exp August 2018)

CLF160016 (Exp August 2018)

CLF160017 (Exp August 2018)

CLF170001 (Exp December 2018)

CLF170023 (Exp May 2019)

CLF170024 (Exp May 2019)

CLF170039 (Exp August 2019)

CLF170040 (Exp August 2019)

CLF170041 (Exp August 2019)

CLF170042 (Exp August 2019)

CLF170043 (Exp August 2019)

CLF170044 (Exp August 2019)

CLF170045 (Exp August 2019)

CLF170046 (Exp August 2019)

CLF170047 (Exp August 2019)

Product: Levofloxacin in 5% Dextrose Injection, 750 mg (5 mg/mL) in 150 mL

Model:

NDC 55150-245-52

Lot Numbers:

CLF160012 (Exp July 2018)

CLF160014 (Exp July 2018)

CLF170007 (Exp February 2019)

CLF170008 (Exp February 2019)

CLF170009 (Exp February 2019)

CLF170010 (Exp February 2019)

CLF170011 (Exp February 2019)

CLF170012 (Exp February 2019)

CLF170013 (Exp February 2019)

CLF170014 (Exp March 2019)

CLF170015 (Exp March 2019)

CLF170016 (Exp March 2019)

CLF170017 (Exp April 2019)

CLF170018 (Exp April 2019)

CLF170019 (Exp April 2019)

CLF170020 (Exp May 2019)

CLF170021 (Exp May 2019)

CLF170022 (Exp May 2019)

CLF170035 (Exp August 2019)

CLF170036 (Exp August 2019)

CLF170037 (Exp August 2019)

CLF170038 (Exp August 2019)

CLF170048 (Exp September 2019)

CLF170049 (Exp September 2019)

CLF170050 (Exp September 2019)

CLF170051 (Exp September 2019)

CLF170052 (Exp September 2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79772

Status: Resolved

Manufacturer: AuroMedics Pharma LLC

Sold By: Hospitals; Healthcare Facilities

Manufactured In: India, United States

Units Affected: 7 products (395150 bags; 46824 bags; 261250 bags; 188941 bags; 67300 bags; 308472 bags; 308112 bags)

Distributed To: Nationwide

Agency Last Updated: February 4, 2019