Central Admixture Pharmacy Services, Inc.: Drug Recall

Recall #D-0659-2023 · 04/28/2023

Class II: Risk

Recall Details

Recall Number: D-0659-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Central Admixture Pharmacy Services, Inc.
Status: Terminated
Date Initiated: 04/28/2023
Location: Allentown, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 350 bags

Reason for Recall

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

Product Description

Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-0101-1.

Distribution Pattern

Nationwide in the USA.

Other Recalls by Central Admixture Pharmacy Services, Inc.

Class I: Dangerous 02/20/2025

Presence of Particulate Matter
Class II: Risk 09/21/2023

Lack of assurance of sterility:
Class II: Risk 09/21/2023

Lack of assurance of sterility:
Class II: Risk 09/21/2023

Lack of assurance of sterility:
Class II: Risk 09/21/2023

Lack of assurance of sterility:

View all recalls by Central Admixture Pharmacy Services, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.