September 2013 FDA Recall Drug by Fallon Wellness Pharmacy Llc
D-66200-001 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Fallon Wellness Pharmacy Llc on September 5, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in NY & ME and the recall is currently terminated.

Recall Number: D-66200-001

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.
Initiated
09-05-2013
Reported
11-06-2013
Quantity
241 prefilled syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66200
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fallon Wellness Pharmacy Llc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NY & ME
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-28-2017
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# : 08052013@84, Exp 11/5/2013