Medications & Supplements/Prescription Drugs

Pacifico National, Inc. dba AmEx Pharmacy: Bevacizumab Syringes Recalled for Lack of Assurance of Sterility

Agency Publication Date: September 10, 2019

Summary

Pacifico National, Inc. dba AmEx Pharmacy is recalling two concentrations of Bevacizumab (Avastin) intravitreal injections, which are medications used for eye conditions. The recall affects both 2.5 mg/0.1 mL and 1.25 mg/0.05 mL syringes because there is a lack of assurance regarding the sterility of these repackaged products. Consumers currently using these medications should contact their healthcare provider immediately as non-sterile injections can lead to serious eye infections.

Risk

If an injectable medication is not sterile, it can introduce bacteria or other contaminants directly into the eye. This poses a significant risk of endophthalmitis (a severe internal eye infection) which can lead to permanent vision loss or blindness.

What You Should Do

Identify your medication by checking the label for 'Bevacizumab 2.5 mg/0.1 mL' (Norm-Ject Syringe) or 'Bevacizumab 1.25 mg/0.05 mL' (31G MJ Syringe) repackaged by AmEx Pharmacy at 1515 Elizabeth St. Suite J, Melbourne, FL 32901.
Check the recall numbers D-1849-2019 or D-1850-2019 and verify if your product is within its expiration date, as all lots currently within expiry are affected by this recall.
Stop using these syringes immediately and contact your healthcare provider or pharmacist for guidance on alternative treatments and to report any side effects.
Return any unused syringes to the pharmacy where you received them for a full refund and further instructions.
Contact Pacifico National, Inc. (AmEx Pharmacy) directly at their Melbourne, Florida location for more information regarding this voluntary recall.
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

Drug recall remedy for non-sterile injectables

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

Affected Products

Product: Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection

Model:

D-1849-2019

Lot Numbers:

All lots remaining within expiry

Product: Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection

Model:

D-1850-2019

Lot Numbers:

All lots remaining within expiry

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83702

Status: Resolved

Manufacturer: Pacifico National, Inc. dba AmEx Pharmacy

Sold By: AmEx Pharmacy

Manufactured In: United States

Distributed To: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming, Puerto Rico

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

Identify your medication by checking the label for 'Bevacizumab 2.5 mg/0.1 mL' (Norm-Ject Syringe) or 'Bevacizumab 1.25 mg/0.05 mL' (31G MJ Syringe) repackaged by AmEx Pharmacy at 1515 Elizabeth St. Suite J, Melbourne, FL 32901.

Check the recall numbers D-1849-2019 or D-1850-2019 and verify if your product is within its expiration date, as all lots currently within expiry are affected by this recall.

Stop using these syringes immediately and contact your healthcare provider or pharmacist for guidance on alternative treatments and to report any side effects.

Return any unused syringes to the pharmacy where you received them for a full refund and further instructions.

Contact Pacifico National, Inc. (AmEx Pharmacy) directly at their Melbourne, Florida location for more information regarding this voluntary recall.

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.