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Class II: temporary or reversible health riskTerminated

Nephron Sterile Compounding Center del Nido Cardioplegia Solution 1000 mL Recall

del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV…

Nephron Sterile Compounding Center LLC · West Columbia, SC

Risk level
Class II
Reported by FDA
Jul 27, 2022
Recall ID
D-1269-2022
Check your lot numberHow we source this data

Summary

Nephron Sterile Compounding Center recalled del Nido Cardioplegia Solution 1000 mL starting Jun 30, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1269-2022 on Jul 27, 2022. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the USA

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-1269-2022
Classification
Class II
Status
Terminated
Recall initiated
Jun 30, 2022
FDA report date
Jul 27, 2022
Quantity
1765 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Nephron Sterile Compounding Center LLC

Original FDA data

Every field from FDA enforcement report D-1269-2022, exactly as published.

Show all FDA fields
City
West Columbia
State
SC
Status
Terminated
Country
United States
Event ID
90512
Address
4500 12th Street Ext
Code information
Lots: NC2031A, Exp. 7/7/2022; NC2033A, Exp. 7/12/2022; NC2034A, Exp. 7/18/2022; NC2035A, Exp. 7/19/2022
Postal code
29172-3025
Report date
Jul 27, 2022
Product type
Drugs
Recall number
D-1269-2022
Classification
Class II
Recalling firm
Nephron Sterile Compounding Center LLC
Product quantity
1765 bags
Termination date
Jun 17, 2024
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide in the USA
Recall initiation date
Jun 30, 2022
Initial firm notification
Letter
Center classification date
Jul 18, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1269-2022, published Jul 27, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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