Class III · Low risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect Product Formulation
Cardioplegia Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0008-1
Affected NDC
72196-0008-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1022-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Central Admixture Pharmacy Services, Inc.
All 2023 recalls
Class II · Moderate risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect product formulation: bag did not contain copper and famotidine per label.
Class I · High risk
PHENYLephrine added to 0.9% sodium chloride
Presence of Particulate Matter
Class II · Moderate risk
HYDROmorphone in dextrose 5%
Lack of assurance of sterility:
Other sterility / contamination recalls from 2023
All sterility / contamination recalls
Class II · Moderate risk
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose
Lack of Sterility Assurance
Class II · Moderate risk
ceFAZolin sodium in Sterile Water for injection
Lack of assurance of sterility.
Class I · High risk
Up&Up brand dry eye relief
Non-Sterility
Class I · High risk
Rugby brand Lubricating Tears Eye Drops
Non-Sterility
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