Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Ceftriaxone for Injection Recalled for Shredded Rubber Particles in Vials

Agency Publication Date: January 9, 2019

Summary

Lupin Pharmaceuticals Inc. is recalling approximately 58,792 units of Ceftriaxone for Injection USP (250 mg, 500 mg, 1 g, and 2 g strengths) because consumers reported seeing grey flecks in the medication after it was prepared for injection. These flecks were identified as shredded rubber particles coming from the vial's stopper. If you have this medication, contact your healthcare provider or pharmacist immediately to determine if your supply is affected.

Risk

Injecting a medication containing rubber particles can cause serious health issues, including local irritation, swelling, or more severe complications if the particles travel through the bloodstream to the lungs or other organs. While the firm initiated this recall following product complaints, the presence of foreign matter in an injectable drug is considered a critical safety risk.

What You Should Do

Check your Ceftriaxone for Injection USP vials for the following NDC numbers and lot details: 250 mg (NDC 68180-611-01/10, Lots C600142, C600136, C600182, C700147, C700207); 500 mg (NDC 68180-622-01/10, Lots C600173, C600218, C600126, C600127, C600137, C600143, C600219, C700146, C700208, C700209); 1 g (NDC 68180-633-01/10, Lots C600110, C600130, C700113, C700143, C600106, C600108, C600128, C600138, C600174, C600179, C600180, C600181, C700108, C700109, C700110, C700111, C700112, C700129, C700130, C700131, C700132, C700138, C700142, C700145); or 2 g (NDC 68180-644-01/10, Lot C600109, C600129, C600135).
Immediately stop using the affected medication and contact your healthcare provider or pharmacist for guidance on alternative treatments.
Return any unused vials or boxes of the recalled medication to the pharmacy where they were purchased for a refund.
Contact Lupin Pharmaceuticals Inc. at their Baltimore office (111 S Calvert St Fl 21ST, Baltimore, MD 21202) for further instructions regarding this recall.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Full Refund

Healthcare provider contact and pharmacy refund

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

Affected Products

Product: Ceftriaxone for Injection USP (250 mg)

Model:

NDC 68180-611-01

NDC 68180-611-10

Lot Numbers:

C600142 (Exp 08/19)

C600136 (Exp 08/19)

C600182 (Exp 09/19)

C700147 (Exp 05/20)

C700207 (Exp 09/20)

Date Ranges: Expiration 08/19, Expiration 09/19, Expiration 05/20, Expiration 09/20

Product: Ceftriaxone for Injection USP (500 mg)

Model:

NDC 68180-622-01

NDC 68180-622-10

Lot Numbers:

C600173 (Exp 08/19)

C600218 (Exp 09/19)

C600126 (Exp 08/19)

C600127 (Exp 08/19)

C600137 (Exp 08/19)

C600143 (Exp 08/19)

C600219 (Exp 09/19)

C700146 (Exp 05/20)

C700208 (Exp 09/20)

C700209 (Exp 09/20)

Date Ranges: Expiration 08/19, Expiration 09/19, Expiration 05/20, Expiration 09/20

Product: Ceftriaxone for Injection USP (1 g)

Model:

NDC 68180-633-01

NDC 68180-633-10

Lot Numbers:

C600110 (Exp 05/19)

C600130 (Exp 08/19)

C700113 (Exp 03/20)

C700143 (Exp 05/20)

C600106 (Exp 05/19)

C600108 (Exp 05/19)

C600128 (Exp 08/19)

C600138 (Exp 08/19)

C600174 (Exp 09/19)

C600179 (Exp 09/19)

C600180 (Exp 09/19)

C600181 (Exp 09/19)

C700108 (Exp 03/20)

C700109 (Exp 03/20)

C700110 (Exp 03/20)

C700111 (Exp 03/20)

C700112 (Exp 03/20)

C700129 (Exp 05/20)

C700130 (Exp 05/20)

C700131 (Exp 05/20)

C700132 (Exp 05/20)

C700138 (Exp 05/20)

C700142 (Exp 05/20)

C700145 (Exp 05/20)

Date Ranges: Expiration 05/19, Expiration 08/19, Expiration 03/20, Expiration 09/19, Expiration 05/20

Product: Ceftriaxone for Injection USP (2 g)

Model:

NDC 68180-644-01

NDC 68180-644-10

Lot Numbers:

C600109 (Exp 05/19)

C600129 (Exp 08/19)

C600135 (Exp 08/19)

Date Ranges: Expiration 05/19, Expiration 08/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81796

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States, India

Units Affected: 4 products (a) 12,000 vials; b) 11,763 boxes; a) 8,000 vials; b) 32,045 boxes; a) 35,000 vials; b) 112,641 boxes; 3,792 boxes)

Distributed To: Nationwide

Agency Last Updated: January 14, 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

Risk

What You Should Do

Check your Ceftriaxone for Injection USP vials for the following NDC numbers and lot details: 250 mg (NDC 68180-611-01/10, Lots C600142, C600136, C600182, C700147, C700207); 500 mg (NDC 68180-622-01/10, Lots C600173, C600218, C600126, C600127, C600137, C600143, C600219, C700146, C700208, C700209); 1 g (NDC 68180-633-01/10, Lots C600110, C600130, C700113, C700143, C600106, C600108, C600128, C600138, C600174, C600179, C600180, C600181, C700108, C700109, C700110, C700111, C700112, C700129, C700130, C700131, C700132, C700138, C700142, C700145); or 2 g (NDC 68180-644-01/10, Lot C600109, C600129, C600135).

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

Return any unused vials or boxes of the recalled medication to the pharmacy where they were purchased for a refund.

Contact Lupin Pharmaceuticals Inc. at their Baltimore office (111 S Calvert St Fl 21ST, Baltimore, MD 21202) for further instructions regarding this recall.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: Ceftriaxone for Injection USP (250 mg)

Model:

NDC 68180-611-01

NDC 68180-611-10

Lot Numbers:

C600142 (Exp 08/19)

C600136 (Exp 08/19)

C600182 (Exp 09/19)

C700147 (Exp 05/20)

C700207 (Exp 09/20)

Date Ranges: Expiration 08/19, Expiration 09/19, Expiration 05/20, Expiration 09/20

Product: Ceftriaxone for Injection USP (500 mg)

Model:

NDC 68180-622-01

NDC 68180-622-10

Lot Numbers:

C600173 (Exp 08/19)

C600218 (Exp 09/19)

C600126 (Exp 08/19)

C600127 (Exp 08/19)

C600137 (Exp 08/19)

C600143 (Exp 08/19)

C600219 (Exp 09/19)

C700146 (Exp 05/20)

C700208 (Exp 09/20)

C700209 (Exp 09/20)

Date Ranges: Expiration 08/19, Expiration 09/19, Expiration 05/20, Expiration 09/20

Product: Ceftriaxone for Injection USP (1 g)

Model:

NDC 68180-633-01

NDC 68180-633-10

Lot Numbers:

C600110 (Exp 05/19)

C600130 (Exp 08/19)

C700113 (Exp 03/20)

C700143 (Exp 05/20)

C600106 (Exp 05/19)

C600108 (Exp 05/19)

C600128 (Exp 08/19)

C600138 (Exp 08/19)

C600174 (Exp 09/19)

C600179 (Exp 09/19)

C600180 (Exp 09/19)

C600181 (Exp 09/19)

C700108 (Exp 03/20)

C700109 (Exp 03/20)

C700110 (Exp 03/20)

C700111 (Exp 03/20)

C700112 (Exp 03/20)

C700129 (Exp 05/20)

C700130 (Exp 05/20)

C700131 (Exp 05/20)

C700132 (Exp 05/20)

C700138 (Exp 05/20)

C700142 (Exp 05/20)

C700145 (Exp 05/20)

Date Ranges: Expiration 05/19, Expiration 08/19, Expiration 03/20, Expiration 09/19, Expiration 05/20

Product: Ceftriaxone for Injection USP (2 g)

Model:

NDC 68180-644-01

NDC 68180-644-10

Lot Numbers:

C600109 (Exp 05/19)

C600129 (Exp 08/19)

C600135 (Exp 08/19)

Date Ranges: Expiration 05/19, Expiration 08/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81796

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States, India

Units Affected: 4 products (a) 12,000 vials; b) 11,763 boxes; a) 8,000 vials; b) 32,045 boxes; a) 35,000 vials; b) 112,641 boxes; 3,792 boxes)

Distributed To: Nationwide

Agency Last Updated: January 14, 2019