Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, 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.
Reported: April 15, 2015 Initiated: December 17, 2014 #D-449-2015
Product Description
Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, 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.
Reason for Recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Details
- Recalling Firm
- Central Admixture Pharmacy Services, Inc.
- Units Affected
- 10 bags
- Distribution
- Nationwide
- Location
- Allentown, PA
Frequently Asked Questions
What product was recalled? ▼
Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, 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.. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 10 bags.
Why was this product recalled? ▼
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 15, 2015. Severity: Critical. Recall number: D-449-2015.
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