Central Admixture Pharmacy Recalls Contaminated Low Potassium Cardioplegia
Central Admixture Pharmacy Services is recalling Low Potassium Cardioplegia doses due to non-sterility and Aspergillus contamination.
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 agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling four doses of Low Potassium Cardioplegia 792 mL. The product is a prescription-only medication manufactured in Livonia, Michigan.
The recall was initiated because the product was found to be non-sterile, with microbial contamination identified as Aspergillus species. The affected lots are numbered 13-920739-01 through 13-920739-04 and have an expiration date of June 21, 2014.
The recalled product was distributed in Michigan and Wisconsin. Healthcare facilities and patients who have received this specific product should contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Cardioplegia
- Affected units
- 4
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 # 13-920739-01 through Lot # 13-920739-04 (4 total doses) 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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