FDA Recall D-0869-2016
Pacifico National, Inc. dba AmEx Pharmacy · Melbourne, FL
Class I — life-threatening Terminated 779 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Reason for recall
Non-Sterility: Product tested positive for bacterial contamination.
Recall record
- Recall number
D-0869-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide
- Recall initiated
- 2015-01-20
- Classified by FDA Center
- 2016-05-25
- FDA published
- 2016-06-01
- Terminated
- 2017-03-09
- Recalling firm
- Pacifico National, Inc. dba AmEx Pharmacy
- Firm location
- Melbourne, FL