Medications & Supplements/Prescription Drugs

Advanced Pharma Inc.: Phenylephrine HCl Injection Recalled for Incorrect Concentration Labeling

Agency Publication Date: December 21, 2018

Summary

Advanced Pharma Inc. is recalling 225 syringes of Phenylephrine HCl, 1 mg in Sterile Water for Injection, a medication used to treat low blood pressure. The product label incorrectly lists the concentration as 10 mcg per mL, when the actual strength is 100 mcg per mL. This labeling error was discovered during a review and affects products distributed to healthcare facilities in New Mexico, Texas, and Ohio.

Risk

The label error states a concentration that is ten times lower than the actual amount of medication in the syringe. This discrepancy poses a critical risk because healthcare providers may accidentally administer a much higher dose than intended, leading to severe adverse health consequences.

What You Should Do

Check your medical supplies for Phenylephrine HCl, 1 mg in Sterile Water for Injection (10 mL syringe) with NDC 42852-802-61.
Verify the specific identification details: look for Lot 11/01/18 8847 80261S with a Beyond Use Date (BUD) of 03/31/19.
Immediately stop using any syringes matching this lot and NDC number.
Contact your healthcare provider or pharmacist for guidance regarding any potential health concerns or if you have been administered this medication.
Return any unused syringes to the pharmacy or place of purchase for a refund and contact Advanced Pharma Inc. at (877) 794-0404 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

Healthcare provider consultation and pharmacy return.

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

Affected Products

Product: Phenylephrine HCl, 1 mg in Sterile Water for Injection, 1 mg/10 mL (10 mL syringe)

Model:

NDC: 42852-802-61

Lot Numbers:

11/01/18 8847 80261S (BUD: 03/31/19)

Date Ranges: BUD: 03/31/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81685

Status: Resolved

Manufacturer: Advanced Pharma Inc.

Sold By: Avella of Houston; Healthcare facilities

Manufactured In: United States

Units Affected: 225 syringes

Distributed To: New Mexico, Texas, Ohio

Agency Last Updated: January 7, 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 medical supplies for Phenylephrine HCl, 1 mg in Sterile Water for Injection (10 mL syringe) with NDC 42852-802-61.

Verify the specific identification details: look for Lot 11/01/18 8847 80261S with a Beyond Use Date (BUD) of 03/31/19.

Immediately stop using any syringes matching this lot and NDC number.

Contact your healthcare provider or pharmacist for guidance regarding any potential health concerns or if you have been administered this medication.

Return any unused syringes to the pharmacy or place of purchase for a refund and contact Advanced Pharma Inc. at (877) 794-0404 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.