Class II · Moderate risk
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe
Lack of assurance of sterility.
Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Drug: Bevacizumab
- Recalling firm
- Pine Pharmaceuticals, LLC
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0583-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Bevacizumab recalls
See all
Class II · Moderate risk
bevacizumab
Lack of Assurance of Sterility
Class II · Moderate risk
Bevacizumab
Lack of Sterility Assurance
Class II · Moderate risk
Bevacizumab 1.25 MG/0.05 ML Solution for Injection
Lack of Assurance of Sterility
Class III · Low risk
Bevacizumab 2.5 mg/0.1 mL
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Other recalls by Pine Pharmaceuticals, LLC
All 2015 recalls
Class II · Moderate risk
Foscarnet Sodium 2.4mg/0.1 mL solution for injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration
Lack of Assurance of Sterility
Class II · Moderate risk
Tropi-Phen
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl 4% ophthalmic solution
Lack of Assurance of Sterility
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