The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1560-2014·Announced 2014-09-03

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.

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 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
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

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 →

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