FDA Recall D-0870-2016

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) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.

Lot / code: Lot #: 150116B, Exp. 04/16/2015; 150119R, Exp. 04/19/2015; 150316H, Exp. 06/14/2015

Quantity: 836 syringes

Non-Sterility: Product tested positive for bacterial contamination.

Recall number: D-0870-2016
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