CLASS II Drug recall · Reported 6 Nov 2013 · FDA Enforcement Report
Bevacizumab 25mg/mL, prepared as pre-filled syringes recalled
Fallon Wellness Pharmacy is recalling Bevacizumab 25mg/mL, prepared as pre-filled syringes in and sizes, Fallon Wellness, distributed in Maine, New York. The recall was initiated on 5 Sep 2013 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-66200-001
- FDA event ID
- 66200
- Recalling firm
- Fallon Wellness Pharmacy, Latham, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Sep 2013
- FDA classified
- 25 Oct 2013
- Reported
- 6 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
Timeline
| 5 Sep 2013 | Recall initiated by company | |
| 25 Oct 2013 | Classified by FDA | +50 days |
| 6 Nov 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.
Product as listed by the FDA
Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110.
Where it was distributed
NY & ME
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.
Which lots are affected?
Lot #: 08052013@84, Exp 11/5/2013
Where was it sold?
NY & ME
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.
More recalls from Fallon Wellness Pharmacy
All 13Other 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 |