Agency classClass IIOur severity:High FDA (Drugs)·D-1038-2023·Announced 2023-08-09

Cardioplegia Solution Recalled Due to Inadequate Sterility Assurance

Central Admixture Pharmacy Services is recalling cardioplegia solution IV bags nationwide due to lack of validated sterilization processes. The recall affects 184 bags from two lots.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a sterile injectable product with demonstrated sterilization process validation deficiency. No reported illnesses, injuries, or confirmed contamination. The hazard is theoretical based on process control failure rather than confirmed microbial contamination, meeting the criterion for High: risk-of-harm product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling cardioplegia solution IV bags (low K maintenance, 4:1 Plasmalyte/Tromethamine, 1000 mL per bag) due to deficiency in sterilization assurance. The recall is based on a finding that validation data for the manufacturer's decontamination cycles is lacking, meaning the company cannot confirm the product meets required sterility standards.

The recalled product consists of 184 IV bags distributed nationwide. The affected lots are: Lot 36-251456 (expiration 7/14/2023) and Lot 36-256020 (expiration 7/28/2023). The product is manufactured by Central Admixture Pharmacy Services, Inc., Phoenix, Arizona (NDC: 72196-0112-1).

Healthcare facilities that received this product should discontinue use and contact the manufacturer for instructions on return or replacement. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product: CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0112-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Sterile Injectable Solution
Hazard: sterility-assurance
validation-deficiency
Affected units: 184

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Lot: 36-251456
Exp. 7/14/2023
36-256020
Exp. 7/28/2023.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 95 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 95 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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