Recalls / Class II
Class IID-1117-2023
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1
- Affected lot / code info
- Lot# 36-260022, Exp 8/19/2023 ;
Why it was recalled
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2200 S 43rd Ave, N/A, Phoenix, Arizona 85043-3909
Distribution
- Quantity
- 104 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-17
- FDA classified
- 2023-08-28
- Posted by FDA
- 2023-09-06
- Terminated
- 2025-03-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1117-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.