Medications & Supplements/Prescription Drugs

Spectrum Laboratory Products: Fentanyl Citrate Recalled for Potential Glass Contamination

Agency Publication Date: October 15, 2019

Summary

Spectrum Laboratory Products is recalling 29.1 grams of Fentanyl Citrate USP, an active pharmaceutical ingredient, due to a notice from a supplier regarding potential glass contamination. The affected products were distributed to compounding pharmacies and laboratories in California, Colorado, Maryland, and South Carolina. Using medication contaminated with glass fragments can lead to serious health complications, such as internal irritation or physical injury at the site of administration.

Risk

The presence of glass fragments in a pharmaceutical ingredient poses a risk of physical trauma, such as internal cuts, irritation, or blockages, particularly if the contaminated ingredient is compounded into an injectable or liquid medication.

What You Should Do

Locate any containers of Fentanyl Citrate USP from Spectrum Chemical MFG. CORP. (NDC 49452-0032-06) and check the labels for lot numbers 1HE0899 or 1IB0005 with an expiration date of 02/28/2023.
Immediately stop using these specific lots and quarantine the product to ensure it is not used in any medical compounding or laboratory testing.
Contact your healthcare provider or pharmacist for guidance if you have recently received medication that may have used this specific ingredient.
Return any unused portion of the affected product to the pharmacy or place of purchase for a refund and contact Spectrum Laboratory Products for further instructions.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare consultation 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: Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP. (29.1 grams)

Model:

NDC 49452-0032-06

Recall #: D-0141-2020

Lot Numbers:

1HE0899 (Exp 02/28/2023)

1IB0005 (Exp 02/28/2023)

Date Ranges: Expires 02/28/2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83796

Status: Resolved

Manufacturer: Spectrum Laboratory Products

Sold By: compounding pharmacies; laboratories

Manufactured In: United States

Units Affected: 29.1 grams

Distributed To: California, Colorado, Maryland, South Carolina

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

Locate any containers of Fentanyl Citrate USP from Spectrum Chemical MFG. CORP. (NDC 49452-0032-06) and check the labels for lot numbers 1HE0899 or 1IB0005 with an expiration date of 02/28/2023.

Immediately stop using these specific lots and quarantine the product to ensure it is not used in any medical compounding or laboratory testing.

Contact your healthcare provider or pharmacist for guidance if you have recently received medication that may have used this specific ingredient.

Return any unused portion of the affected product to the pharmacy or place of purchase for a refund and contact Spectrum Laboratory Products for further instructions.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).