Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Microdroplets
Pine Pharmaceuticals is recalling specific lots of 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (injection of particulate matter) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Pine Pharmaceuticals, LLC is recalling Bevacizumab 2 mg/0.08 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 lots are 1837@2 with an expiration date of 1/17/2016, and 1646@6 with an expiration date of 12/20/2015. The product was distributed nationwide and in Puerto Rico.
Healthcare providers and patients should stop using the affected syringes and contact Pine Pharmaceuticals for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Category
- Drug — Ophthalmic
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 (4)
- Lot #: 1837@2
- exp. 1/17/2016
- 1646@6
- exp. 12/20/2015
Distribution
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.
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