Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Alprostadil Injection Recalled for Failed Impurity and Degradation Limits

Agency Publication Date: November 14, 2018

Summary

Approximately 1,362 vials of Alprostadil Injection USP (500 micrograms/mL) have been recalled because routine stability testing revealed levels of impurities and degradation that exceeded approved safety specifications. This prescription medication, commonly used for heart-related conditions in infants, was distributed across the United States, including Puerto Rico and Hawaii. Consumers should be aware that the 1 mL single-use vials packaged 5 per carton are affected. Because this is a prescription drug, patients and caregivers should consult with a medical professional immediately to discuss alternative treatments and safe returns.

Risk

The presence of impurities or degradation products beyond specified limits can reduce the effectiveness of the medication or potentially introduce unexpected side effects. While no specific injuries have been reported, using out-of-specification drugs poses a risk to patients, particularly infants who are the primary recipients of this specific treatment.

What You Should Do

Check your medication packaging for Alprostadil Injection USP 500 micrograms/mL (1 mL single-use vial) with NDC 0703-1501-02.
Verify the lot number and expiration date on the vial or carton: look for Lot # 31323147B with an expiration date of 01/2019.
If you have the affected lot, contact your healthcare provider or pharmacist immediately for guidance on using an alternative supply.
Return any unused product from this specific lot to the pharmacy where it was purchased for a refund.
Contact Teva Pharmaceuticals USA for further instructions regarding this recall at their corporate office or through the distribution contact at 1090 Horsham Rd, North Wales, Pennsylvania.
For additional questions or to report side effects, 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 consultation and pharmacy refund.

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

Affected Products

Product: Alprostadil Injection USP 500 micrograms/mL (1 mL single use vial)

Model:

NDC 0703-1501-02

Recall #: D-0244-2019

Lot Numbers:

31323147B (Exp 01/2019)

Date Ranges: 01/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81120

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: Hospitals; Pharmacies

Manufactured In: United States

Units Affected: 1,362 vials

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

Risk

What You Should Do

Check your medication packaging for Alprostadil Injection USP 500 micrograms/mL (1 mL single-use vial) with NDC 0703-1501-02.

Verify the lot number and expiration date on the vial or carton: look for Lot # 31323147B with an expiration date of 01/2019.

If you have the affected lot, contact your healthcare provider or pharmacist immediately for guidance on using an alternative supply.

Return any unused product from this specific lot to the pharmacy where it was purchased for a refund.

Contact Teva Pharmaceuticals USA for further instructions regarding this recall at their corporate office or through the distribution contact at 1090 Horsham Rd, North Wales, Pennsylvania.

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