CLASS II Drug recall · Reported 27 Jan 2016 · FDA Enforcement Report
Bevacizumab 2 mg/ in 5/16" Syringe for intravitreal recalled
Pine Pharmaceuticals is recalling Bevacizumab 2 mg/ in 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100, distributed nationwide in the US. The recall was initiated on 4 Nov 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0583-2016
- FDA event ID
- 72629
- Recalling firm
- Pine Pharmaceuticals, Tonawanda, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2015
- FDA classified
- 20 Jan 2016
- Reported
- 27 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 4 Nov 2015 | Recall initiated by company | |
| 20 Jan 2016 | Classified by FDA | +77 days |
| 27 Jan 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Which lots are affected?
Lot #: 1837@2, exp. 1/17/2016; 1646@6, exp. 12/20/2015
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 72629This product is part of a recall event; the main page for the event is Bevacizumab 1.25 mg/ in 5/16" Syringe recalled by Pine Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bevacizumab 1.25 mg/ in 5/16" Syringe recalled by Pine Pharmaceuticals | Pine Pharmaceuticals | Particulate Matter | Nationwide | |
| CLASS II | Bevacizumab 2.5 mg/ in 5/16" Syringe recalled by Pine Pharmaceuticals | Pine Pharmaceuticals | Particulate Matter | Nationwide | |
| CLASS II | Bevacizumab 1.25 mg/ filled to in 5/16" Syringe recalled | Pine Pharmaceuticals | Particulate Matter | Nationwide |
More recalls from Pine Pharmaceuticals
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Foscarnet Sodium 2.4mg/ solution recalled by Pine Pharmaceuticals | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Endophth Kit (Vancomycin 1mg/ - Ceftazidime 2.25mg recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Bevacizumab 1.25 MG/ Solution for Injection syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic recalled | Pine Pharmaceuticals | Sterility | Nationwide |
Other Bevacizumab recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bevacizumab 1.75 mg/ - syringe, Intravitreal Total Volume recalled | RC Outsourcing | Sterility | Nationwide |
| Drug | CLASS II | Bevacizumab 1.25 MG/ Solution for Injection syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS III | Bevacizumab 2.5 mg/, Solution for Injection recalled | Pine Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Bevacizumab, 1.25 mg/ MJ Syringe Intravitreal Injection recalled | Pacifico National | Sterility | PR |
| Drug | CLASS II | Bevacizumab, 2.5 mg/, Norm-Ject Syringe Intravitreal recalled | Pacifico National | Sterility | PR |