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TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

FDA Recall #D-1020-2016 — Class II — May 17, 2016

Recall #D-1020-2016 Date: May 17, 2016 Classification: Class II Status: Terminated

Product Description

TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Reason for Recall

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

Recalling Firm

Well Care Compounding Pharmacy — Las Vegas, NV

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

869 Units (Total All Products)

Distribution

NV

Code Information

Lot #: 12302015:53@18, Exp.04/29/2016; Lot #: 03142016:67@53, Exp. 06/12/2016; Lot #: 03302016: 43@38, Exp. 06/28/2016; Lot #: 03/292016: 30@23, Exp. 06/29/2016.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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