Medications & Supplements/Prescription Drugs

Advanced Pharma Inc.: Magnesium Sulfate 0.9% Sodium Chloride Injection Recalled for Subpotency

Agency Publication Date: January 23, 2018

Summary

Advanced Pharma Inc. is recalling 25 bags of MAGnesium 2 gm in NS 100 mL (magnesium sulfate 0.9% sodium chloride) because the medication is subpotent, meaning it contains less active ingredient than required. This prescription drug is a sterile, single-dose infusion bag used for intravenous magnesium replacement. This specific batch was distributed exclusively to healthcare facilities in Texas and may not provide the full intended dose to patients.

Risk

A subpotent medication may fail to deliver the prescribed therapeutic dose, potentially leading to inadequate treatment of magnesium deficiency or other conditions requiring magnesium supplementation. This could result in uncontrolled symptoms or a delay in patient recovery depending on the severity of the patient's condition.

What You Should Do

Identify if you have the affected MAGnesium 2 gm in NS 100 mL Sterile single dose bags by checking for Lot: 12/22/17 1422 108-90710P with a Use By date (UD) of 3/22/2018.
Check the product label for NDC 42852-907-10 and ensure the packaging matches the 'Avella of Houston' description at 9265 Katy Dr., Houston, TX.
Immediately stop using any infusion bags matching these specific lot and identification numbers.
Contact your healthcare provider or pharmacist immediately if you have been administered this medication to discuss alternative treatments or concerns.
Return any remaining unused product to the pharmacy or place of purchase for a refund and contact Advanced Pharma Inc. at 9265 Kirby Dr, Houston, Texas for further instructions.
For additional questions, 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

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

Affected Products

Product: MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) Sterile single dose bag

Model:

NDC 42852-907-10

Recall #: D-0575-2018

Lot Numbers:

12/22/17 1422 108-90710P (UD: 3/22/2018)

Date Ranges: Use By: 3/22/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78889

Status: Resolved

Manufacturer: Advanced Pharma Inc.

Sold By: Avella of Houston

Manufactured In: United States

Units Affected: 25 bags

Distributed To: Texas

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

Identify if you have the affected MAGnesium 2 gm in NS 100 mL Sterile single dose bags by checking for Lot: 12/22/17 1422 108-90710P with a Use By date (UD) of 3/22/2018.

Check the product label for NDC 42852-907-10 and ensure the packaging matches the 'Avella of Houston' description at 9265 Katy Dr., Houston, TX.

Immediately stop using any infusion bags matching these specific lot and identification numbers.

Contact your healthcare provider or pharmacist immediately if you have been administered this medication to discuss alternative treatments or concerns.

Return any remaining unused product to the pharmacy or place of purchase for a refund and contact Advanced Pharma Inc. at 9265 Kirby Dr, Houston, Texas for further instructions.

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