Bevacizumab recalled over sterility concerns

Recall date

August 30, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pacifico National, Inc. dba AmEx Pharmacy recalls Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Phar…

Recall number

D-1849-2019

FDA classification

Class II

Brand / firm

Pacifico National, Inc. dba AmEx Pharmacy

Sold / distributed

Continental U.S. and Puerto Rico

Why it was recalled

Lack of assurance of sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901