Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Microdroplets
Pine Pharmaceuticals is recalling specific lots of bevacizumab syringes for intravitreal use due to the presence of 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 agency classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or those not explicitly stated as having no reported illness, are categorized as Severe (Score 4).
Plain-English summary
Pine Pharmaceuticals, LLC is recalling specific lots of Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringes for intravitreal use. The recall is being conducted because of the presence of particulate matter, specifically silicone oil microdroplets, in the syringes.
The affected lots are 1648@7 with an expiration date of 12/20/2015, and 1428@4 with an expiration date of 11/17/2015. These products were distributed nationwide and in Puerto Rico.
Healthcare providers and patients should stop using the affected syringes and contact Pine Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- 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.
- 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 #: 1648@7
- exp. 12/20/2015
- 1428@4
- exp. 11/17/2015
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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