Rose Medical Center recall: Sterility Concern
Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 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.
Why was Rose Medical Center recalled?
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lot number 37-74756, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74756-0-8-R, Disp ID: 37-1124668.
- Product
- Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 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.
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Quantity
- 8 bags
- Distribution
- Nationwide
- Recall date
- April 15, 2015
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)