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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Event Detail

Event ID 66200
Product Type Drugs
Status Ongoing
Recalling Firm Fallon Wellness Pharmacy Llc
City Latham
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-05
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern NY & ME

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110. Lot #: 08052013@84, Exp 11/5/2013 Class II 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. 241 prefilled syringes D-66200-001