FDA Drug recall D-0581-2016

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, Ton…

FDA Drug
Class II
terminated
Published 2016-01-27

On 2016-01-27 the FDA classified a Class II recall of 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, Ton… by Pine Pharmaceuticals, citing presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0581-2016
Classification	Class II
Status	terminated
Initiated	2015-11-04
Published	2016-01-27
Last updated	2026-09-13 11:51 UTC
Company	Pine Pharmaceuticals
Distribution	US

Product

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.

Reason

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

Identifiers

code_info	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. 2/1/201… 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/

code_info

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. 2/1/201…

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/

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0581-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.