FDA Drug recall D-0994-2016

M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

FDA Drug
Class II
terminated
Published 2016-06-15

On 2016-06-15 the FDA classified a Class II recall of M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 by Well Care Compounding Pharmacy, citing lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0994-2016
Classification	Class II
Status	terminated
Initiated	2016-05-17
Published	2016-06-15
Last updated	2026-09-13 11:51 UTC
Company	Well Care Compounding Pharmacy
Distribution	NV

Product

M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Reason

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Identifiers

code_info	Lot #: 01042016: 45@46, Exp. 07/02/2016; Lot #:01112016: 87@46, Exp. 07/10/2016; Lot #:01112016:78@63, Exp. 07/10/2… Lot #: 01042016: 45@46, Exp. 07/02/2016; Lot #:01112016: 87@46, Exp. 07/10/2016; Lot #:01112016:78@63, Exp. 07/10/2016; Lot #: 01272016:81@30, Exp.07/25/2016; Lot #: 02102016:89@2, Exp. 08/08/2016; 02162016:25@57, Exp.08/14/2016; 02262016:33@54, Exp.08/24/2016; Lot #: 03092016:64@51, Exp.09/07/2016; Lot #: 04142016:01@45, Exp.10/11/2016 04142016:17@37, Exp.10/15/2016; 04282016:72@48, Exp.10/29/2016.

code_info

Lot #: 01042016: 45@46, Exp. 07/02/2016; Lot #:01112016: 87@46, Exp. 07/10/2016; Lot #:01112016:78@63, Exp. 07/10/2…

Lot #: 01042016: 45@46, Exp. 07/02/2016; Lot #:01112016: 87@46, Exp. 07/10/2016; Lot #:01112016:78@63, Exp. 07/10/2016; Lot #: 01272016:81@30, Exp.07/25/2016; Lot #: 02102016:89@2, Exp. 08/08/2016; 02162016:25@57, Exp.08/14/2016; 02262016:33@54, Exp.08/24/2016; Lot #: 03092016:64@51, Exp.09/07/2016; Lot #: 04142016:01@45, Exp.10/11/2016 04142016:17@37, Exp.10/15/2016; 04282016:72@48, Exp.10/29/2016.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0994-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.