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.
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 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Pine Pharmaceuticals, LLC
See all →- HighFDA Recalls Compounded Moxifloxacin Syringes for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-25
- HighTPC Drops Ophthalmic Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-25
- HighFoscarnet Sodium Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-10-25
- HighLidocaine eye drops recalled due to lack of sterility assurance
FDA (Drugs) · 2023-10-25
- HighEndophth Kit Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-10-25
Same hazard · particulate matter
See all →- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateBevacizumab Injection Recall Due to Incorrect Lot Number Labeling
FDA (Drugs) · 2023-04-19
- HighCompounded Bevacizumab Injectable Syringes Recalled for Sterility Assurance
FDA (Drugs) · 2023-10-25
- SevereFDA Recalls Bevacizumab Intravitreal Injection Due to Sterility Concerns
FDA (Drugs) · 2019-09-18
- SevereMylan Recalls Cytarabine Injection Vials Due to Particulate Matter
FDA (Drugs) · 2015-08-19
- HighBevacizumab intravitreal syringes recalled for lack of sterility assurance
FDA (Drugs) · 2025-10-15
- SevereLupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter
FDA (Drugs) · 2019-01-16