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Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1. Class II

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

Central Admixture Pharmacy Services, Inc. 20230428 Terminated
Distributed: Nationwide in the USA.
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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., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1. Class II

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

Central Admixture Pharmacy Services, Inc. 20230428 Terminated
Distributed: Nationwide in the USA.
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Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0008-1. Class II

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

Central Admixture Pharmacy Services, Inc. 20230428 Terminated
Distributed: Nationwide in the USA.
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Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0007-1. Class II

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

Central Admixture Pharmacy Services, Inc. 20230428 Terminated
Distributed: Nationwide in the USA.
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Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0006-1. Class II

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

Central Admixture Pharmacy Services, Inc. 20230428 Terminated
Distributed: Nationwide in the USA.
View Details
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. Class II

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

Central Admixture Pharmacy Services, Inc. 20230428 Terminated
Distributed: Nationwide in the USA.
View Details
Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0002-1. Class II

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

Central Admixture Pharmacy Services, Inc. 20230428 Terminated
Distributed: Nationwide in the USA.
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Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0001-1. Class II

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

Central Admixture Pharmacy Services, Inc. 20230428 Terminated
Distributed: Nationwide in the USA.
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VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25 Class II

Reason: Lack of Assurance of Sterility

Apollo Care, LLC 20230502 Ongoing
Distributed: Missouri only
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FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25 Class II

Reason: Lack of Assurance of Sterility

Apollo Care, LLC 20230502 Ongoing
Distributed: Missouri only
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