D-0395-2017 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
- 2,264 kits (number of vials per kit vary by prescription)
Product Description
Sermorelin Acetate/GHRP (2) 9 mg/3 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: 04152016@149, 05182016@176, 06172016@142, 07272016@83, 08232016@32, 09122016@138. Known vial lot code: 04072016@91, 04262016@27, 05272016@41, 07192016@29, 08192016@18, 09062016@44.