FDA Drug recall D-0582-2016
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…
- FDA Drug
- Class II
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class II recall of 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… by Pine Pharmaceuticals, citing presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0582-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-04 |
| Published | 2016-01-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pine Pharmaceuticals |
| Distribution | US |
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.
Reason
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Identifiers
| code_info | Lot #: 1648@7, exp. 12/20/2015; 1428@4, exp. 11/17/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0582-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.