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Recall Observatory FDA recall evidence

Drug product

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

D-1849-2019

August 30, 2019

Class II

Product summary

Firm
Pacifico National, Inc. dba AmEx Pharmacy
Event
Event 83702
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-1849-2019

Official wording

Reason: Lack of assurance of sterility.

Code information: All lots remaining within expiry.

Distribution pattern: Continental U.S. and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility