CLASS II Drug recall · Reported 18 Sep 2019 · FDA Enforcement Report

Bevacizumab, 1.25 mg/ MJ Syringe Intravitreal Injection recalled

Pacifico National is recalling Bevacizumab, 1.25 mg/ MJ Syringe Intravitreal Injection, Single use only, distributed in Puerto Rico. The recall was initiated on 30 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots remaining within expiry.

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1850-2019
FDA event ID: 83702
Recalling firm: Pacifico National, Melbourne, FL
Classification: Class II
Status: Terminated
Recall initiated: 30 Aug 2019
FDA classified: 10 Sep 2019
Reported: 18 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

30 Aug 2019	Recall initiated by company
10 Sep 2019	Classified by FDA	+11 days
18 Sep 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of assurance of sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901

Where it was distributed

Continental U.S. and Puerto Rico

Puerto Rico

Questions about this recall

Why was it recalled?

Lack of assurance of sterility.

Which lots are affected?

All lots remaining within expiry.

Where was it sold?

Continental U.S. and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 83702

This product is part of a recall event; the main page for the event is Bevacizumab, 2.5 mg/, Norm-Ject Syringe Intravitreal recalled.

Reported	Class	Recall	Company	Reason	Where
18 Sep 2019	CLASS II	Bevacizumab, 2.5 mg/, Norm-Ject Syringe Intravitreal recalled	Pacifico National	Sterility	PR

More recalls from Pacifico National

All 5

Reported	Class	Recall	Company	Reason	Where
18 Sep 2019Drug	CLASS II	Bevacizumab, 2.5 mg/, Norm-Ject Syringe Intravitreal recalled	Pacifico National	Sterility	PR
8 May 2019Drug	CLASS II	Bevacizumab 1.25 mg/ MJ syringe Intravitreal Injection recalled	Pacifico National	Packaging Defects	Nationwide
1 Jun 2016Drug	CLASS I	Avastin (Bevacizumab) 1.25 mg/ syringe recalled by Pacifico National	Pacifico National	Sterility	Nationwide
1 Jun 2016Drug	CLASS I	Avastin (Bevacizumab) 2 mg/ syringe recalled by Pacifico National	Pacifico National	Sterility	Nationwide

Other Bevacizumab recalls

All 16

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Bevacizumab 1.75 mg/ - syringe, Intravitreal Total Volume recalled	RC Outsourcing	Sterility	Nationwide
25 Oct 2023Drug	CLASS II	Bevacizumab 1.25 MG/ Solution for Injection syringes recalled	Pine Pharmaceuticals	Sterility	Nationwide
19 Apr 2023Drug	CLASS III	Bevacizumab 2.5 mg/, Solution for Injection recalled	Pine Pharmaceuticals	Packaging Defects	Nationwide
18 Sep 2019Drug	CLASS II	Bevacizumab, 2.5 mg/, Norm-Ject Syringe Intravitreal recalled	Pacifico National	Sterility	PR
21 Aug 2019Drug	CLASS II	Bevacizumab 784 MG / Ns Ivpb recalled by Infusion Options	Infusion Options	Sterility	NY