The Recall Desk
HighFDA (Drugs)·D-1269-2022·Announced 2022-07-27

FDA Recalls Nephron Cardioplegia Solution Over Sterility Assurance Concerns

Nephron Sterile Compounding Center is recalling del Nido Cardioplegia Solution due to lack of assurance of sterility. The 1765 bags affected were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a medical product with critical sterility concerns for use in cardiac surgery. The hazard of lack of sterility assurance poses significant risk, though no contamination or adverse events have been reported.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling 1765 bags of del Nido Cardioplegia Solution due to lack of assurance of sterility. This solution is a sterile injectable medication used during cardiac surgical procedures.

The affected lots are: NC2031A (expires 7/7/2022), NC2033A (expires 7/12/2022), NC2034A (expires 7/18/2022), and NC2035A (expires 7/19/2022). The product was distributed nationwide in the United States.

Healthcare facilities that may have received this product should verify their inventory against the lot numbers listed above to determine if they have any affected items.

The recalled product

Product
del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable Solution / Compounded Medication
Hazard
Affected units
1,765

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 (8)

  • Lots: NC2031A
  • Exp. 7/7/2022
  • NC2033A
  • Exp. 7/12/2022
  • NC2034A
  • Exp. 7/18/2022
  • NC2035A
  • Exp. 7/19/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 37 recalled by Nephron Sterile Compounding Center LLC 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.

See all 37 products in this recall →

Related recalls

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · sterility assurance

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