FDA-Drug2015-04-15Class I

Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 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
12 bags
Manufactured in
6580 Snowdrift Rd Ste 100, N/A, Allentown, PA, United States
Products
Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 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-470-2015

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