FDA-Drug2015-04-15Class I
Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, 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.
Central Admixture Pharmacy Services, Inc.
Hazard
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Sold states
Nationwide
Affected count
4 bags
Manufactured in
6580 Snowdrift Rd Ste 100, N/A, Allentown, PA, United States
Products
Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-450-2015Don't want to check this manually?
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