The Recall Desk
CriticalFDA (Drugs)·D-1562-2014·Announced 2014-09-03

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.

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 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
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

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 →