# FDA recall D-0584-2016

> **Pine Pharmaceuticals, LLC** · Class II · drug recall initiated 2015-11-04.

## 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.

## Reason for recall

Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0584-2016
- **Recalling firm:** Pine Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-11-04
- **Report date:** 2016-01-27
- **Termination date:** 2017-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tonawanda, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0584-2016

## Citation

> AI Analytics. FDA recall D-0584-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0584-2016. Source: US FDA. Licensed CC0.

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