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FDAFDA · Food and drugs·Recall number D-1361-2016

0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 ,

Published July 27, 2016 · Recall initiated: May 5, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Pharmedium Services, LLC
Distributor
Nationwide
Lot
Lot # 160420165M; Exp. 05/16 Lot # 160540128M; Exp. 05/16 Lot # 160630117M; Exp. 06/16 Lot # 160770157M; Exp. 06/16 Lot # 160870055M; Exp. 06/16 Lot # 160890153M; Exp. 06/16 Lot # 160950340M; Exp. 07/16
Risk classification
Class II
Area (FDA)
drug
Country
United States

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