Reported May 31, 2023 · Terminated
Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only,…
Central Admixture Pharmacy Services, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Central Admixture Pharmacy Services, Inc. · 6580 Snowdrift Rd Ste 100 · Allentown, PA · 18106-9331
Is this the product you have?
- Cardioplegia Solution
- Reperfusate 41 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1
- Lot codes and dates
Lot # 37-893848Exp 04/28/202337-895681Exp 05/05/202337-899250Exp 05/19/202337-901355Exp 05/27/2023
- Amount recalled
- 254 bags
This recall covers 108 products
The agency filed one notice per product. You are reading one of them; the other 107 are below.
95 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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