Status
Terminated
Drug Enforcement D-66200-001
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.
Classification
Class II
Report Date
November 6, 2013
Termination Date
February 28, 2017
Product Information
- 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.
- Product quantity
- 241 prefilled syringes
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- NY & ME
Location & Firm
- Recalling firm
- Fallon Wellness Pharmacy Llc
- Address
-
1057 Troy Schenectady Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-66200-001
- Event ID
- 66200
- Recall initiation date
- September 5, 2013
- Center classification date
- October 25, 2013
- Code info
- Lot #: 08052013@84, Exp 11/5/2013
- More code info
- —