FDAClass IIJanuary 27, 2016

Bevacizumab 1.25 mg/0.05 mL filled to recall: Particulate Matter

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…

Why was Bevacizumab 1.25 mg/0.05 mL filled to recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 1648@7, exp. 12/20/2015; 1428@4, exp. 11/17/2015

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…
Recalling firm
Pine Pharmaceuticals, LLC
Quantity
N/A
Distribution
Nationwide and Puerto Rico
Recall date
January 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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