D-0351-2017 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
- 908 kits (number of vials per kit vary by prescription)
Product Description
Chorionic Gonadotropin Lyophilized, 20,000 unit 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:04212016@42, 06092016@164, 08122016@96. Known vial lot code: 04132016@96, 05242016@1, 08082016@50.