FDA Recall D-1559-2014
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
PEDIATRIC CARDIOPLEGIA, 255 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-1559-2014- 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