Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110.

FDA recall notice · announced November 6, 2013 · Fallon Wellness Pharmacy

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110.

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.

Notes

Distribution: NY & ME
Lot/code information: Lot #: 08052013@84, Exp 11/5/2013
Quantity: 241 prefilled syringes
Status: Terminated
Products in this recall event:
- Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110. (D-66200-001)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.