CLASS II Drug recall · Reported 9 Aug 2023 · FDA Enforcement Report
Cardioplegia Solution, 106 mEq K recalled by Central Admixture Pharmacy
Central Admixture Pharmacy Services is recalling Cardioplegia Solution, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium, distributed nationwide in the US. The recall was initiated on 14 Jul 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1029-2023
- FDA event ID
- 92707
- Recalling firm
- Central Admixture Pharmacy Services, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jul 2023
- FDA classified
- 1 Aug 2023
- Reported
- 9 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Jul 2023 | Recall initiated by company | |
| 1 Aug 2023 | Classified by FDA | +18 days |
| 9 Aug 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0204-1
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Cardioplegia Solution, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium recalled?
Yes. Central Admixture Pharmacy Services recalled Cardioplegia Solution, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium on 14 Jul 2023. The recall is Class II and its status is Terminated. Recall number D-1029-2023.
Why was it recalled?
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Which lots are affected?
Lot:36-253949, Exp. 7/20/2023; 36-255411, Exp. 7/23/2023.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Central Admixture Pharmacy Services
All 347Other Cardioplegia recalls
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Cardioplegia Solution, 24 mEq K, Maintenance 8:1 recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Cardioplegia Solution, 20 mEq K, Maintenance 4:1 recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Cardioplegia Solution del Nido Formula, Total Volume =, EVA recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Cardioplegia Solution, 60 mEq K, Induction 4:1 recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |