Recalls / Class I
Class ID-458-2015
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
Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10%, 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.
- Affected lot / code info
- lot numbers 37-74792 and 37-74635, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74792-0-2-R and CAPS Rx: 37-74635-0-2-R, Disp ID: 37-1124677 and Disp ID: 37-1124679
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
- 4 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-458-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.