CMC Enterprise Pharmacy Recalls DelNido Cardioplegia Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 110 bags of DelNido Cardioplegia in North Carolina due to a lack of sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in a medical product, which poses a significant risk of serious injury or infection.
Plain-English summary
CMC Enterprise Pharmacy is recalling 110 bags of DelNido Cardioplegia. The product is a cardiac perfusion solution containing Mannitol, Potassium Chloride, Sodium Bicarbonate, Lidocaine, and Magnesium Sulfate, intended for use in cardiac perfusion only and not for intravenous use.
The recall was initiated due to a lack of sterility assurance. The affected lots are ED041909 (expiration date 4/13/2019) and ED111907 (expiration date 4/20/2019). The product was distributed in North Carolina.
Healthcare providers and patients should stop using the recalled product and contact CMC Enterprise Pharmacy for further instructions or a replacement.
The recalled product
- Product
- DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, Made by…
- Manufacturer
- CMC Enterprise Pharmacy
- Hazard
- Affected units
- 110
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: ED041909 Exp. 4/13/2019
- ED111907 Exp. 4/20/2019
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 32 recalled by CMC Enterprise Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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