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Class II: temporary or reversible health riskTerminated

Pacifico National, Inc. dba AmEx Pharmacy Bevacizumab Recall

Bevacizumab, 1

Pacifico National, Inc. dba AmEx Pharmacy · Melbourne, FL

Risk level
Class II
Reported by FDA
Sep 18, 2019
Recall ID
D-1850-2019
Check your lot numberHow we source this data

Summary

Pacifico National, Inc. dba AmEx Pharmacy recalled Bevacizumab starting Aug 30, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1850-2019 on Sep 18, 2019. Reason: Lack of assurance of sterility. Status: Terminated.

Why it was recalled

Lack of assurance of sterility.

Product description

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

Lot numbers, UPCs & expiration codes

All lots remaining within expiry.

Where it was sold

Continental U.S. and Puerto Rico

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1850-2019
Classification
Class II
Status
Terminated
Recall initiated
Aug 30, 2019
FDA report date
Sep 18, 2019
Recall type
Voluntary: Firm initiated
Recalling firm
Pacifico National, Inc. dba AmEx Pharmacy

Original FDA data

Every field from FDA enforcement report D-1850-2019, exactly as published.

Show all FDA fields
City
Melbourne
State
FL
Status
Terminated
Country
United States
Event ID
83702
Address
1515 Elizabeth St Ste J
Code information
All lots remaining within expiry.
Postal code
32901-3000
Report date
Sep 18, 2019
Product type
Drugs
Recall number
D-1850-2019
Classification
Class II
Recalling firm
Pacifico National, Inc. dba AmEx Pharmacy
Termination date
Oct 8, 2020
Reason for recall
Lack of assurance of sterility.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Continental U.S. and Puerto Rico
Recall initiation date
Aug 30, 2019
Initial firm notification
Press Release
Center classification date
Sep 10, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1850-2019, published Sep 18, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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