FDA Recall D-465-2015

Central Admixture Pharmacy Services, Inc. · Allentown, PA

Class I — life-threatening Terminated 245 days on record

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

Product

Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Lot / code: lot number 37-74776, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74776-0-3-R, Disp ID: 37-1124585

Quantity: 3 bags

Reason for recall

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Recall record

Recall number: D-465-2015
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Telephone
Distribution: Nationwide
Recall initiated: 2014-12-17
Classified by FDA Center: 2015-04-08
FDA published: 2015-04-15
Terminated: 2015-08-19
Recalling firm: Central Admixture Pharmacy Services, Inc.
Firm location: Allentown, PA

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