Recalls / Class I
Class ID-453-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additives: heparin PF 0.5 unit(s)/mL, Calcium Gluconate 600mg, 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.
- Affected lot / code info
- lot number 37-74680, Made on 15 DEC 2014, EXP 24 DEC 2014,CAPS Rx: 37-74680-0-6-R, Disp ID: 37-1124687
Why it was recalled
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6580 Snowdrift Rd Ste 100, N/A, Allentown, Pennsylvania 18106-9331
Distribution
- Quantity
- 6 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-12-17
- FDA classified
- 2015-04-08
- Posted by FDA
- 2015-04-15
- Terminated
- 2015-08-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-453-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.