Agency classClass IIOur severity:Severe FDA (Drugs)·D-0581-2016·Announced 2016-01-27

Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Particulates

Pine Pharmaceuticals is recalling Bevacizumab syringes for intravitreal use because they contain silicone oil microdroplets.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a drug administered intravitreally (into the eye) is categorized as Severe due to the potential for significant injury or adverse health consequences from particulate matter.

Plain-English summary

Pine Pharmaceuticals, LLC is recalling Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringes for intravitreal use. The recall is due to the presence of particulate matter, specifically silicone oil microdroplets, in the syringes.

The affected products were distributed nationwide and in Puerto Rico. The recall covers numerous lots with expiration dates ranging from November 2015 to February 2016. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should stop using the affected Bevacizumab syringes and contact Pine Pharmaceuticals for further instructions on how to return the product.

The recalled product

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.
Manufacturer: Pine Pharmaceuticals, LLC
Category: Drug — Ophthalmic
Hazard: particulate-matter
silicone-oil

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot #: 1956@2
exp. 2/2/2016
1954@1
1958@3
1943@2
exp. 2/1/2016
1942@1
1944@3
1938@1
exp. 1/31/2016
1939@2
1931@1
exp. 1/28/2016
1932@2
1935@3
1925@1
exp. 1/27/2016
1927@2
1928@3
1913@3

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Pine Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Pine Pharmaceuticals, LLC

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Same hazard · particulate matter