D-0385-2017 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
- 114 vials and b) 1,017 vials
Product Description
QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 mg/mL Injectable, a) 2 mL and b) 5 mL vials, 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. a) Known lot code: 04072016@8, 06272016@22, 09082016@29 b) Known lot code: 04142016@16, 04272016@8, 06102016@13, 07062016@29, 08052016@1.