Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Particulates
Pine Pharmaceuticals is recalling specific lots of bevacizumab syringes for intravitreal injection because they contain silicone oil microdroplets.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, as it involves a product that may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Pine Pharmaceuticals, LLC is recalling specific lots of Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringes for intravitreal injection. The recall was initiated due to the presence of particulate matter, specifically silicone oil microdroplets, in the syringes.
The affected product is a prescription medication intended for intravitreal injection. The recall covers lots 1918@5, 1820@5, 1773@5, 1665@5, 1542@5, and 1544@6. These lots were distributed nationwide and in Puerto Rico.
Healthcare providers and patients should check their inventory and medication records for these specific lot numbers and expiration dates. If the product is found, it should be quarantined and not used. Patients should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- 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.
- 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 (12)
- Lot #: 1918@5
- exp. 1/26/2016
- 1820@5
- exp. 1/12/2016
- 1773@5
- exp. 1/6/2016
- 1665@5
- exp. 12/22/2015
- 1542@5
- exp. 12/1/2015
- 1544@6
- exp. 12/1/2015.
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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