Why it was recalled
Non Sterility; microbial contamination identified as Aspergillus species
Product description
PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Lot numbers, UPCs & expiration codes
Lot # 13-920741-0-1 EXP 21 JUN 2014
Where it was sold
Michigan and Wisconsin
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1559-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 28, 2014
- FDA report date
- Sep 3, 2014
- Quantity
- 1 dose
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-1559-2014, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 68532
- Address
- 37497 Schoolcraft Rd
- Code information
- Lot # 13-920741-0-1 EXP 21 JUN 2014
- Postal code
- 48150-1007
- Report date
- Sep 3, 2014
- Product type
- Drugs
- Recall number
- D-1559-2014
- Classification
- Class I
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 1 dose
- Termination date
- Sep 19, 2014
- Reason for recall
- Non Sterility; microbial contamination identified as Aspergillus species
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
- Distribution pattern
- Michigan and Wisconsin
- Recall initiation date
- May 28, 2014
- Initial firm notification
- Telephone
- Center classification date
- Aug 25, 2014