FDA Recall D-1823-2015

Pharmedium Services, LLC · Lake Forest, IL

Class I — life-threatening Terminated 730 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50

Lot / code: Lot #: 143140080M, Exp 02/09/15; 143210133M, Exp 02/16/15; 143490031M, Exp 03/16/15

Quantity: 20 bags

Reason for recall

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Recall record

Recall number: D-1823-2015
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide
Recall initiated: 2015-01-28
Classified by FDA Center: 2015-09-23
FDA published: 2015-09-30
Terminated: 2017-01-27
Recalling firm: Pharmedium Services, LLC
Firm location: Lake Forest, IL

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