PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported September 18, 2019

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

Lack of assurance of sterility.

Recall #
D-1849-2019
Initiated
August 30, 2019
Verify with FDA Drug →
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Pacifico National, Inc. dba AmEx Pharmacy recalled Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx… - a moderate-severity action.

Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx… was recalled by Pacifico National, Inc. dba AmEx Pharmacy in September 18, 2019. Reason: Lack of assurance of sterility.. Check the official notice for the remedy. Verify recall #D-1849-2019 with the FDA Drug before acting.

The recall

Pacifico National, Inc. dba AmEx Pharmacy issued this moderate-severity FDA Drug recall-Lack of assurance of sterility..

Moderate
severity level
Class II
classification
September 18, 2019
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1849-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,472 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 448
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

Reason for recall

Lack of assurance of sterility.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-1849-2019
Date reported September 18, 2019
Date initiated August 30, 2019
Recalling firm Pacifico National, Inc. dba AmEx Pharmacy
Firm location Melbourne, FL
Affected scope Not disclosed
Distribution Continental U.S. and Puerto Rico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-1849-2019) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product 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. Recalled by Pacifico National, Inc. dba AmEx Pharmacy.
Why was this product recalled?
Lack of assurance of sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 18, 2019. Severity: Moderate. Recall number: D-1849-2019.
Where was the recalled product distributed?
Distribution: Continental U.S. and Puerto Rico.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

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This recall: FDA Drug, reported September 18, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026