CLASS I Drug recall · Reported 15 Apr 2015 · FDA Enforcement Report
Bridgeport Hospital (CT)TPN Neonatal Standard Solution recalled
Central Admixture Pharmacy Services is recalling Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, distributed nationwide in the US. The recall was initiated on 17 Dec 2014 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-442-2015
- FDA event ID
- 70148
- Recalling firm
- Central Admixture Pharmacy Services, Allentown, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Dec 2014
- FDA classified
- 8 Apr 2015
- Reported
- 15 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Blood Thinners
Timeline
| 17 Dec 2014 | Recall initiated by company | |
| 8 Apr 2015 | Classified by FDA | +112 days |
| 15 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, 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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Which lots are affected?
lot number 37-74654 Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74654-0-4-R, Disp ID: 37-1124511
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
33 other products · FDA event 70148This product is part of a recall event; the main page for the event is Virginia Hospital Center (VA) TPN Neonatal Day recalled.