D-0340-2017 Class II Terminated

Recalled by Wells Pharmacy Network LLC — Ocala, FL

FDA drug recall D-0340-2017 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: 351 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
351 vials

Product Description

Arginine HCl 100 mg/mL Injectable,10 mL, Compounded by Wells Pharmacy Network, LLC, 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 lot code: 05122016@3, 07072016@15, 08302016@65

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0340-2017
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.