Medications & Supplements/Prescription Drugs

Advanced Pharma Inc.: Hydromorphone Injectable Solution Recalled for Sub-potency

Agency Publication Date: April 29, 2019

Summary

Advanced Pharma Inc. is recalling 560 bags of Hydromorphone 20 mg/100 mL (generic Dilaudid) injectable solution because the medication is sub-potent, meaning it contains less active ingredient than specified. This compounded drug was distributed in 100 mL sterile single-use bags through Avella of Houston. Because the medication is weaker than expected, patients may not receive the necessary level of pain relief, which could lead to inadequate treatment of severe pain.

Risk

The drug is sub-potent and fails to meet strength specifications, which can result in under-dosing. For patients requiring significant pain management, this lack of efficacy can lead to untreated pain and potential clinical complications.

What You Should Do

Immediately check your medical supplies for Hydromorphone 20 mg/100 mL Injectable Solution in 0.9% Sodium Chloride sterile single-use bags.
Verify if your product matches Lot 01/14/19 0215 22110P with an Expiration Date of 04/29/2019 and NDC 42852-221-10.
Contact your healthcare provider or pharmacist immediately for guidance if you have this medication, as you may require an alternative supply for pain management.
Return any unused bags of the affected medication to the place of purchase (Avella of Houston) for a refund.
Contact Advanced Pharma Inc. or Avella of Houston at (877) 794-0404 for further instructions regarding the return process.
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

Contact healthcare provider and return product

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

Affected Products

Product: HYDROmorphone 20 mg/100 mL Injectable Solution (Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL)

Model:

NDC: 42852-221-10

Recall #: D-1251-2019

Lot Numbers:

01/14/19 0215 22110P (Exp. 04/29/2019)

Date Ranges: Expiration Date: 04/29/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82718

Status: Resolved

Manufacturer: Advanced Pharma Inc.

Sold By: Avella of Houston

Manufactured In: United States

Units Affected: 560 bags

Distributed To: Nationwide

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

Immediately check your medical supplies for Hydromorphone 20 mg/100 mL Injectable Solution in 0.9% Sodium Chloride sterile single-use bags.

Verify if your product matches Lot 01/14/19 0215 22110P with an Expiration Date of 04/29/2019 and NDC 42852-221-10.

Contact your healthcare provider or pharmacist immediately for guidance if you have this medication, as you may require an alternative supply for pain management.

Return any unused bags of the affected medication to the place of purchase (Avella of Houston) for a refund.

Contact Advanced Pharma Inc. or Avella of Houston at (877) 794-0404 for further instructions regarding the return process.

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.