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D-0383-2017 Class II Terminated

Recalled by Wells Pharmacy Network LLC — Ocala, FL

FDA drug recall D-0383-2017 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: a) 1,165 vials b) 2,217 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: a) 1,165 vials b) 2,217 vials

Product Description

QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 5 mL vials, 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. a) Known lot code: 04122016@17, 04142016@14, 05112016@23, 06072016@17, 06232016@13, 07122016@41, 08052016@12 b) Known lot code: 03242016@8, 04142016@15, 05032016@11, 05262016@12, 06242016@11, 07122016@42, 08052016@11.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0383-2017
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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