Drug & medication recalls Moderate risk

Pine Pharmaceuticals, LLC recalls Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Col…

Recall date
November 4, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0584-2016
FDA classification
Class II
Brand / firm
Pine Pharmaceuticals, LLC
Sold / distributed
Nationwide and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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