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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- 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
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.
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