The Recall Desk
CriticalFDA (Drugs)·D-1561-2014·Announced 2014-09-03

Adenosine Injection Recalled for Microbial Contamination

Central Admixture Pharmacy Services is recalling adenosine 90 mg injections in Michigan and Wisconsin due to Aspergillus species 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 recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling adenosine 90 mg in 0.9% sodium chloride/90 mL, a prescription-only medication. The recall involves five specific doses distributed in Michigan and Wisconsin. The product was identified as non-sterile due to microbial contamination with Aspergillus species.

The affected lots are numbered 13-920757-0-1 through 13-920757-0-5, with an expiration date of July 6, 2014. This recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

Healthcare providers and patients should discontinue use of the affected adenosine injections and contact the manufacturer or their local FDA office for further instructions on disposal or replacement.

The recalled product

Product
adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Affected units
5

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# 13-920757-0-1 through Lot# 13-920757-0-5 (5 total doses) EXP 06 JUL 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 →