Home / Recalls / Wells Pharmacy Network LLC / D-0364-2017

D-0364-2017 Class II Terminated

Recalled by Wells Pharmacy Network LLC — Ocala, FL

FDA drug recall D-0364-2017 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: 189 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: 189 vials

Product Description

Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, 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 lot code: 04062016@3, 04252016@4, 05172016@4, 06162016@6, 07212016@8.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0364-2017
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.

Other recalls by Wells Pharmacy Network LLC

D-0373-2017 Class II — MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by… (Sep 21, 2016)
D-0401-2017 Class II — Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial… (Sep 21, 2016)
D-0350-2017 Class II — Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by… (Sep 21, 2016)
D-0344-2017 Class II — Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells… (Sep 21, 2016)
D-0331-2017 Class II — Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells… (Sep 21, 2016)
D-0327-2017 Class II — Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL… (Sep 21, 2016)
D-0421-2017 Class II — Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells… (Sep 21, 2016)
D-0341-2017 Class II — Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials… (Sep 21, 2016)
D-0415-2017 Class II — Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials… (Sep 21, 2016)
D-0355-2017 Class II — DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL Solution, 50 mL bottle… (Sep 21, 2016)