D-66200-001 Class II Terminated
FDA drug recall D-66200-001 was initiated by Fallon Wellness Pharmacy Llc on September 5, 2013 and is designated Class II. 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 reporte… The recall status is terminated (terminated February 28, 2017). Affected quantity: 241 prefilled syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2013
- Initiation Date
- September 5, 2013
- Termination Date
- February 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 241 prefilled syringes
Product Description
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.
Distribution Pattern
NY & ME
Code Information
Lot #: 08052013@84, Exp 11/5/2013