Medications & Supplements/Prescription Drugs

Apotex Corp.: Enoxaparin Sodium Injection Recalled for Incorrect Dosage Markings

Agency Publication Date: February 9, 2021

Summary

Apotex Corp. is voluntarily recalling 13,502 units of Enoxaparin Sodium Injection, USP (generic Lovenox) because of a labeling mix-up on the syringe barrels. Some syringes for the 100 mg/mL strength may have markings for the 150 mg/mL strength, and vice versa. This defect was found in two specific batches manufactured by Gland Pharma Ltd., involving 10 x 1 mL and 10 x 0.8 mL single-dose syringe cartons distributed nationwide.

Risk

The incorrect markings on the syringe barrel could lead to patients receiving an incorrect dose of the medication—either too much or too little. An incorrect dose of this blood-thinning medication can result in serious health consequences, such as excessive bleeding or the failure to prevent dangerous blood clots.

What You Should Do

Check your medication packaging for Enoxaparin Sodium Injection, USP 100 mg/mL (10 x 1 mL cartons) with NDC 60505-0795-4, UPC 360505079544, and Batch CS008 with expiration date 04/2022.
Check your medication packaging for Enoxaparin Sodium Injection, USP 120 mg/0.8 mL (10 x 0.8 mL cartons) with NDC 60505-0796-4, UPC 360505079543, and Batch CT003 with expiration date 05/2022.
If your medication matches the affected batch numbers (CS008 or CT003), contact your healthcare provider or pharmacist immediately for guidance on how to obtain a safe replacement and to discuss your treatment.
Return any unused or affected syringes to the pharmacy where you purchased them for a refund.
Contact Apotex Corp. at their headquarters or through your distributor for further instructions regarding the return of these specific lots.
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

Return to pharmacy for refund and clinical guidance.

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

Affected Products

Product: Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes (10 x 1 mL)

Model:

NDC 60505-0795-4

NDC 60505-0795-1

UPC Codes:

360505079544

10360505079510

Lot Numbers:

CS008 (Exp. 04/2022)

Date Ranges: Expiration 04/2022

Product: Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes (10 x 0.8 mL)

Model:

NDC 60505-0796-4

NDC 60505-0796-0

UPC Codes:

360505079543

10360505079602

Lot Numbers:

CT003 (Exp. 05/2022)

Date Ranges: Expiration 05/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87269

Status: Active

Manufacturer: Apotex Corp.

Sold By: pharmacies; hospitals

Manufactured In: India, United States

Units Affected: 2 products (6670 cartons; 6832 cartons)

Distributed To: Nationwide

Agency Last Updated: February 17, 2021

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 medication packaging for Enoxaparin Sodium Injection, USP 100 mg/mL (10 x 1 mL cartons) with NDC 60505-0795-4, UPC 360505079544, and Batch CS008 with expiration date 04/2022.

Check your medication packaging for Enoxaparin Sodium Injection, USP 120 mg/0.8 mL (10 x 0.8 mL cartons) with NDC 60505-0796-4, UPC 360505079543, and Batch CT003 with expiration date 05/2022.

If your medication matches the affected batch numbers (CS008 or CT003), contact your healthcare provider or pharmacist immediately for guidance on how to obtain a safe replacement and to discuss your treatment.

Return any unused or affected syringes to the pharmacy where you purchased them for a refund.

Contact Apotex Corp. at their headquarters or through your distributor for further instructions regarding the return of these specific lots.

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: Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes (10 x 1 mL)

Model:

NDC 60505-0795-4

NDC 60505-0795-1

UPC Codes:

360505079544

10360505079510

Lot Numbers:

CS008 (Exp. 04/2022)

Date Ranges: Expiration 04/2022

Product: Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes (10 x 0.8 mL)

Model:

NDC 60505-0796-4

NDC 60505-0796-0

UPC Codes:

360505079543

10360505079602

Lot Numbers:

CT003 (Exp. 05/2022)

Date Ranges: Expiration 05/2022