CLASS II Drug recall · Reported 31 May 2023 · FDA Enforcement Report
Cardioplegia Solution, Induction 4:1 Plasmalyte recalled
Central Admixture Pharmacy Services is recalling Cardioplegia Solution, Induction 4:1 Plasmalyte, High Potassium, High K, distributed nationwide in the US. The recall was initiated on 28 Apr 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-0676-2023
- FDA event ID
- 92253
- Recalling firm
- Central Admixture Pharmacy Services, Allentown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Apr 2023
- FDA classified
- 19 May 2023
- Reported
- 31 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 28 Apr 2023 | Recall initiated by company | |
| 19 May 2023 | Classified by FDA | +21 days |
| 31 May 2023 | Published in enforcement report | +12 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: after an FDA inspection called into question the sterility of the products intended to be sterile.
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, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0212-1.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is Cardioplegia Solution, Induction 4:1 Plasmalyte, High Potassium, High K recalled?
Yes. Central Admixture Pharmacy Services recalled Cardioplegia Solution, Induction 4:1 Plasmalyte, High Potassium, High K on 28 Apr 2023. The recall is Class II and its status is Terminated. Recall number D-0676-2023.
Why was it recalled?
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Which lots are affected?
Lot # 37-895217, Exp 05/04/2023; 37-898803, Exp 05/18/2023; 37-900614, Exp 05/25/2023
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 |