Recalls / Class I
Class ID-1559-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
- Affected lot / code info
- Lot # 13-920741-0-1 EXP 21 JUN 2014
Why it was recalled
Non Sterility; microbial contamination identified as Aspergillus species
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 37497 Schoolcraft Rd, N/A, Livonia, Michigan 48150-1007
Distribution
- Quantity
- 1 dose
- Distribution pattern
- Michigan and Wisconsin
Timeline
- Recall initiated
- 2014-05-28
- FDA classified
- 2014-08-25
- Posted by FDA
- 2014-09-03
- Terminated
- 2014-09-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1559-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.