Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 36-251207, Exp. 7/10/2023; 36-256337, Exp. 7/29/2023.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1004-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2023
- FDA report date
- Aug 9, 2023
- Quantity
- 224 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-1004-2023, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 92707
- Address
- 2200 S 43rd Ave
- Code information
- Lot: 36-251207, Exp. 7/10/2023; 36-256337, Exp. 7/29/2023.
- Postal code
- 85043-3909
- Report date
- Aug 9, 2023
- Product type
- Drugs
- Recall number
- D-1004-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 224 bags
- Termination date
- Mar 28, 2025
- Reason for recall
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 14, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2023