The Recall Desk
CriticalFDA (Drugs)·D-1559-2014·Announced 2014-09-03

Pediatric Cardioplegia Recalled for Aspergillus Microbial Contamination

Central Admixture Pharmacy Services is recalling Pediatric Cardioplegia due to non-sterility and Aspergillus contamination. The product was distributed in Michigan and Wisconsin.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Pediatric Cardioplegia, 255 mL, Rx Only, due to non-sterility. Microbial contamination identified as Aspergillus species was found in the product.

The affected product is identified by Lot # 13-920741-0-1 with an expiration date of 21 JUN 2014. The recall covers one dose per unit. Distribution was limited to Michigan and Wisconsin.

Healthcare providers and patients should discontinue use of the affected lot and contact the recalling firm for further instructions. This recall is classified as Class I by the FDA.

The recalled product

Product
PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Affected units
1

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 (1)

  • Lot # 13-920741-0-1 EXP 21 JUN 2014

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →