FDA-Drug2015-04-15Class I

Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additives: heparin PF 0.5 unit(s)/mL, Calcium Gluconate 600mg, compound vol: 150 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.

Central Admixture Pharmacy Services, Inc.
Hazard

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

Sold states
Nationwide
Affected count
6 bags
Manufactured in
6580 Snowdrift Rd Ste 100, N/A, Allentown, PA, United States
Products
Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additives: heparin PF 0.5 unit(s)/mL, Calcium Gluconate 600mg, compound vol: 150 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-453-2015

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