D-0356-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 11, 2017
- Initiation Date
- September 21, 2016
- Termination Date
- July 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 203 kits (number of vials per kit vary by prescription)
Product Description
Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 06082016@133. Known vial lot code: 05202016@4.