Medications & Supplements/Prescription Drugs

Piramal Critical Care, Inc.: Gablofen (baclofen injection) Recalled for Unknown Impurity

Agency Publication Date: July 28, 2019

Summary

Piramal Critical Care, Inc. is voluntarily recalling 2,155 boxes of Gablofen (baclofen injection), 50 mcg/mL, after an unknown impurity was discovered during routine shelf-life testing. Baclofen is a muscle relaxant used to treat spasms, and this recall affects single-use 1 mL syringes packaged in individual boxes. Consumers should contact their healthcare provider or pharmacist immediately to discuss their treatment and determine if their medication is part of the affected lots.

Risk

The presence of an unknown impurity or degradation product means the medication does not meet its safety and quality specifications. Injecting a product with unidentified impurities could lead to unpredictable adverse reactions or reduced effectiveness of the treatment.

What You Should Do

Check your medication boxes and syringes for Gablofen (baclofen injection), 50 mcg/mL, 1 mL single-use syringes with NDC 66794-151-01.
Verify the lot numbers and expiration dates on the packaging: look for Lot 2155-111 or Lot 2155-111A with an expiration date of June 2020 (Exp 6/20).
If you identify an affected product, contact your healthcare provider or pharmacist immediately to arrange for a replacement and to ensure your treatment is not interrupted.
Return any unused syringes from the affected lots to the pharmacy where they were purchased for a refund and further instruction.
Contact Piramal Critical Care, Inc. directly at their Bethlehem, PA headquarters for specific questions regarding the return process.
For additional questions about this recall, 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

Medical guidance 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: Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe (1 mL)

Model:

NDC 66794-151-01

Recall #: D-1742-2019

Lot Numbers:

2155-111 (Exp 6/20)

2155-111A (Exp 6/20)

Date Ranges: Expiration Date: June 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83280

Status: Resolved

Manufacturer: Piramal Critical Care, Inc.

Sold By: Pharmacies; Healthcare providers

Manufactured In: United States

Units Affected: Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)

Distributed To: Nationwide

Agency Last Updated: August 13, 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 medication boxes and syringes for Gablofen (baclofen injection), 50 mcg/mL, 1 mL single-use syringes with NDC 66794-151-01.

Verify the lot numbers and expiration dates on the packaging: look for Lot 2155-111 or Lot 2155-111A with an expiration date of June 2020 (Exp 6/20).

If you identify an affected product, contact your healthcare provider or pharmacist immediately to arrange for a replacement and to ensure your treatment is not interrupted.

Return any unused syringes from the affected lots to the pharmacy where they were purchased for a refund and further instruction.

Contact Piramal Critical Care, Inc. directly at their Bethlehem, PA headquarters for specific questions regarding the return process.

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