D-0392-2017 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
- 176 kits (number of vials per kit vary by prescription)
Product Description
Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg 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: 04062016@170, 05272016@67, 09132016@98. Known vial lot code: 03302016@12, 050412016@84, 08222016@27.