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FDAApril 28, 2023drug

Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0005-1.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

What to do

FDA enforcement status: Terminated

Brands named

central admixture pharmacy servicescentralcentral admixture

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0005-1. — Recall Details · AllClear