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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

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.
Recall Number D-66200-001
Classification Class II
Code Info Lot #: 08052013@84, Exp 11/5/2013
Product Distributed Qty 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.

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