FDAFDA · Food and drugs·Recall number D-0584-2016
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.
Published January 27, 2016 · Recall initiated: November 4, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pine Pharmaceuticals, LLC
- Distributor
- Nationwide and Puerto Rico
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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