Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.

FDA recall notice · announced January 27, 2016 · Pine Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: 1956@2, exp. 2/2/2016; 1954@1, exp. 2/2/2016; 1958@3, exp. 2/2/2016; 1943@2, exp. 2/1/2016; 1942@1, exp. 2/1/2016; 1944@3, exp. 2/1/2016; 1938@1, exp. 1/31/2016; 1939@2, exp. 1/31/2016; 1931@1, exp. 1/28/2016; 1932@2, exp. 1/28/2016; 1935@3, exp. 1/28/2016; 1925@1, exp. 1/27/2016; 1927@2, exp. 1/27/2016; 1928@3, exp. 1/27/2016; 1913@3, exp. 1/26/2016; 1917@4, exp. 1/26/2016; 1911@1, exp. 1/26/2016; 1921@6, exp. 1/26/2016; 1906@3, exp. 1/25/2016; 1903@1, exp. 1/25/2016; 1904@2, exp. 1/25/2016; 1899@3, exp. 1/24/2016; 1896@2, exp. 1/24/2016; 1895@1, exp. 1/24/2016; 1886@2, exp. 1/21/2016; 1893@5, exp. 1/21/2016; 1890@4, exp. 1/21/2016; 1885@1, exp. 1/21/2016; 1888@3, exp. 1/21/2016; 1879@5, exp. 1/20/2016; 1872@1, exp. 1/20/2016; 1875@3, exp. 1/20/2016; 1873@2, exp. 1/20/2016; 1867@5, exp. 1/19/2016; 1870@6, exp. 1/19/2016; 1866@4, exp. 1/19/2016; 1854@4, exp. 1/18/2016; 1853@5, exp. 1/18/2016; 1855@6, exp. 1/18/2016; 1839@3, exp. 1/17/2016; 1836@1, exp. 1/17/2016; 1831@2, exp. 1/14/2016; 1813@2, exp. 1/14/2016; 1830@1, exp. 1/14/2016; 1825@1, exp. 1/13/2016; 1818@4, exp. 1/13/2016; 1827@2, exp. 1/13/2016; 1816@3, exp. 1/12/2016; 1812@1, exp. 1/13/2016; 1804@4, exp. 12/31/2015; 1799@6, exp. 1/10/2016; 1797@5, exp. 1/10/2016; 1789@3, exp. 1/7/2016; 1635@5, exp. 12/17/2015; 1490@1, exp. 11/25/2015; 1790@4, exp. 1/7/2016; 1633@4, exp. 12/17/2015; 1492@2, exp. 11/25/2015; 1786@1, exp. 1/7/2016; 1628@2, exp. 12/17/2015; 1497@5, exp. 11/25/2015; 1788@2, exp. 1/7/2016; 1629@3, exp. 12/17/2015; 1486@7, exp. 11/24/2015; 1764@1, exp. 1/6/2016; 1617@1, exp. 12/16/2015; 1476@3, exp. 11/24/2015; 1768@3, exp. 1/6/2016; 1623@4, exp. 12/16/2015; 1474@1, exp. 11/24/2015; 1769@4, exp. 1/6/2016; 1620@3, exp. 12/16/2015; 1466@2, exp. 11/23/2015; 1757@2, exp. 1/5/2016; 1625@5, exp. 12/16/2015; 1473@5, exp. 11/23/2015; 1756@1, exp. 1/5/2016; 1618@2, exp. 12/16/2015; 1465@1, exp. 11/23/2015; 1762@4, exp. 1/5/2016; 1608@2, exp. 12/15/2015; 1460@2, exp. 11/22/2015; 1749@3, exp. 1/4/201
Quantity: N/A
Status: Terminated
Products in this recall event:
- Bevacizumab 2 mg/0.08 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-0583-2016)
- 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. (D-0584-2016)
- 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)
- Bevacizumab 1.25 mg/0.05 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-0581-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.