D-0330-2017 Class II Terminated
FDA drug recall D-0330-2017 was initiated by Wells Pharmacy Network LLC on Sep 21, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Jul 2, 2021). Affected quantity: a) 1,312 vials and b) 3,354 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 11, 2017
- Initiation Date
- Sep 21, 2016
- Termination Date
- Jul 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 1,312 vials and b) 3,354 vials
Product Description
QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 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: 03292016@12, 0422016@10, 04222016@10, 05052016@33, 05122016@11, 05132016@19, 05242016@2, 06212016@17, 07262016@36, 09072016@21, 09142015@17 b) Known lot code: 03242016@9, 04112016@10, 04212016@19, 05042016@20, 05132016@21, 05202016@71, 06152016@7, 07122016@21, 08032016@17, 09092016@35.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0330-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026