Recalls / Class II
Class IID-1850-2019
Product
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
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
Lack of assurance of sterility.
Recalling firm
- Firm
- Pacifico National, Inc. dba AmEx Pharmacy
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1515 Elizabeth St Ste J, Melbourne, Florida 32901-3000
Distribution
- Distribution pattern
- Continental U.S. and Puerto Rico
Timeline
- Recall initiated
- 2019-08-30
- FDA classified
- 2019-09-10
- Posted by FDA
- 2019-09-18
- Terminated
- 2020-10-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1850-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.