Recalls / Class I
Class ID-470-2015
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
Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, 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 number 37-74714, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74714-0-12-R, Disp ID: 37-1124493
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
- 12 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-470-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.