Recalls / Class I
Class ID-1561-2014
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
adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
- Affected lot / code info
- Lot# 13-920757-0-1 through Lot# 13-920757-0-5 (5 total doses) EXP 06 JUL 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
- 5 doses
- 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-1561-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.