FDA-Drug2023-05-31Class II
Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1.
Central Admixture Pharmacy Services, Inc.
Hazard
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Sold states
Nationwide in the USA.
Affected count
325 bags
Manufactured in
6580 Snowdrift Rd Ste 100, N/A, Allentown, PA, United States
Products
Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0679-2023Don't want to check this manually?
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