Drug product
Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
D-0582-2016
Product summary
- Event
- Event 72629
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0582-2016
Official wording
Reason: Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Code information: Lot #: 1648@7, exp. 12/20/2015; 1428@4, exp. 11/17/2015
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
particulate matter