Recalls / Class II
Class IID-0584-2016
Product
Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
- Affected lot / code info
- Lot #: 1918@5, exp. 1/26/2016; 1820@5, exp. 1/12/2016; 1773@5, exp. 1/6/2016; 1665@5, exp. 12/22/2015; 1542@5, exp. 12/1/2015; 1544@6, exp. 12/1/2015.
Why it was recalled
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Recalling firm
- Firm
- Pine Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Colvin Woods Pkwy Suite 300, N/A, Tonawanda, New York 14150-6974
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-11-04
- FDA classified
- 2016-01-20
- Posted by FDA
- 2016-01-27
- Terminated
- 2017-03-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0584-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.