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D-0381-2017 Class II Terminated

Recalled by Wells Pharmacy Network LLC — Ocala, FL

FDA drug recall D-0381-2017 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: 219 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: 219 kits (number of vials per kit vary by prescription)

Product Description

NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophilized 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: 04072016@29, 08122016@103. Known vial lot code: 03302016@13, 03252016@16, 08082016@58, 08082016@67.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0381-2017
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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