Bevacizumab 2 mg/0 — Class II drug recall D-0583-2016
Terminated recall by Pine Pharmaceuticals, LLC, reported 2016-01-27, distributed nationwide. Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitrea
| Recall number | D-0583-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pine Pharmaceuticals, LLC, Tonawanda, NY, United States |
| Recall initiated | 2015-11-04 |
| Classified | 2016-01-20 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2017-03-22 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| Expiration dates | 2015-12-20, 2016-01-17 |
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.
Reason for recall
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.