Class III · Low risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect Product Formulation
Pediatric Cardioplegia
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non Sterility; microbial contamination identified as Aspergillus species
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1559-2014 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Central Admixture Pharmacy Services, Inc.
All 2014 recalls
Class II · Moderate risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect product formulation: bag did not contain copper and famotidine per label.
Class I · High risk
PHENYLephrine added to 0.9% sodium chloride
Presence of Particulate Matter
Class II · Moderate risk
HYDROmorphone in dextrose 5%
Lack of assurance of sterility:
Other microbial contamination recalls from 2014
All microbial contamination recalls
Class II · Moderate risk
Entertainer's Secret Throat Relief
Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
Class II · Moderate risk
CVS pharmacy
Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth.
Class II · Moderate risk
Xarelto (rivaroxaban)
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Class II · Moderate risk
Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
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