FDA Recall D-1561-2014
Central Admixture Pharmacy Services, Inc. · Livonia, MI
Class I — life-threatening Terminated 114 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Reason for recall
Non Sterility; microbial contamination identified as Aspergillus species
Recall record
- Recall number
D-1561-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Michigan and Wisconsin
- Recall initiated
- 2014-05-28
- Classified by FDA Center
- 2014-08-25
- FDA published
- 2014-09-03
- Terminated
- 2014-09-19
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Firm location
- Livonia, MI