Home / Recalls / Wells Pharmacy Network LLC / D-0395-2017

D-0395-2017 Class II Terminated

Recalled by Wells Pharmacy Network LLC — Ocala, FL

FDA drug recall D-0395-2017 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: 2,264 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: 2,264 kits (number of vials per kit vary by prescription)

Product Description

Sermorelin Acetate/GHRP (2) 9 mg/3 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: 04152016@149, 05182016@176, 06172016@142, 07272016@83, 08232016@32, 09122016@138. Known vial lot code: 04072016@91, 04262016@27, 05272016@41, 07192016@29, 08192016@18, 09062016@44.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0395-2017
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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