Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Reported: January 27, 2016 Initiated: November 4, 2015 #D-0581-2016
Product Description
Bevacizumab 1.25 mg/0.05 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.
Details
- Recalling Firm
- Pine Pharmaceuticals, LLC
- Units Affected
- N/A
- Distribution
- Nationwide and Puerto Rico
- Location
- Tonawanda, NY
Frequently Asked Questions
What product was recalled? ▼
Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.. Recalled by Pine Pharmaceuticals, LLC. Units affected: N/A.
Why was this product recalled? ▼
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 27, 2016. Severity: Moderate. Recall number: D-0581-2016.
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