Central Admixture Recalls del Nido Cardioplegia Due to Microbial Contamination
Central Admixture Pharmacy Services is recalling del Nido Cardioplegia with Lidocaine due to non-sterility and Aspergillus contamination.
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 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 31 doses of del Nido Cardioplegia with Lidocaine 1052.8 ml. The recall is due to non-sterility, with microbial contamination identified as Aspergillus species.
The affected product is prescription-only and was distributed in Michigan and Wisconsin. The specific lots involved are Lot# 13-920742-0-1 and Lot# 13-920452-0-1 through 13-920452-0-30, all with an expiration date of June 21, 2014.
Healthcare providers and patients should stop using the affected product and contact the recalling firm or their local FDA office for further instructions.
The recalled product
- Product
- del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Cardioplegia Solution
- Affected units
- 31
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 (2)
- Lot# 13-920742-0-1 EXP 21 JUN 2014 and Lot# 13-920452-0-1 through 13-920452-0-30
- 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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