Home / Recalls / Wells Pharmacy Network LLC / D-0389-2017

D-0389-2017 Class II Terminated

Recalled by Wells Pharmacy Network LLC — Ocala, FL

FDA drug recall D-0389-2017 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: 3,089 kits (number of vials per kit vary by prescription).

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: 3,089 kits (number of vials per kit vary by prescription)

Product Description

Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, 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 kit lot code: 05122016@180, 06132016@155, 06232016@147, 07062016@156, 07272016@68, 08232016@24, 09062016@74. Known vial lot code: 04212016@110, 052412016@76, 05312016@40, 06102016@52, 07152016@56, 08192016@20, 08102016@56.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0389-2017
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.

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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)