FDA Recall D-437-2015

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

University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, 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 37-74529, EXP: 24 DEC 2014, Made on 15 DEC 2014, CAPS Rx: 37-74529-0-20-R, Disp ID: 37-1124540

Quantity: 20 bags

Reason for recall

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

Recall record

Recall number: D-437-2015
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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