D-0408-2017 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
- a) 238 vials and b) 607 vials
Product Description
Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, 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: 05042016@19, 06142016@28, 07262016@34, 09072016@22 b) Known lot code: 04112016@8, 05232016@2, 06212016@21, 07012016@22, 09082016@31.