Recalls / Class I
Class ID-0870-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot #: 150116B, Exp. 04/16/2015; 150119R, Exp. 04/19/2015; 150316H, Exp. 06/14/2015
Why it was recalled
Non-Sterility: Product tested positive for bacterial contamination.
Recalling firm
- Firm
- Pacifico National, Inc. dba AmEx Pharmacy
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1515 Elizabeth St Ste J, N/A, Melbourne, Florida 32901-3000
Distribution
- Quantity
- 836 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-01-20
- FDA classified
- 2016-05-25
- Posted by FDA
- 2016-06-01
- Terminated
- 2017-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0870-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.