CLASS II Drug recall · Reported 30 Oct 2019 · FDA Enforcement Report
del Nido Cardioplegia Solution, Single-Dose Container recalled
Nephron Pharmaceuticals is recalling del Nido Cardioplegia Solution, Single-Dose Container, distributed nationwide in the US. The recall was initiated on 9 Oct 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0151-2020
- FDA event ID
- 83999
- Recalling firm
- Nephron Pharmaceuticals, West Columbia, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Oct 2019
- FDA classified
- 18 Oct 2019
- Reported
- 30 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 9 Oct 2019 | Recall initiated by company | |
| 18 Oct 2019 | Classified by FDA | +9 days |
| 30 Oct 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; bags have potential to leak
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; bags have potential to leak
Which lots are affected?
Lots: NC9048A Exp. 10/14/2019; NC9048B Exp. 10/14/2019; NC9049A Exp. 10/16/2019; NC9049B Exp. 10/16/2019; NC9051A Exp. 10/21/2019; NC9051B Exp. 10/21/2019; NC9052A Exp. 10/22/2019; NC9052B Exp. 10/22/2019; NC9053A Exp. 10/23/2019; NC9053B Exp. 10/23/2019; NC9054A Exp. 10/28/2019; NC9054B Exp. 10/28/2019; NC9055A Exp. 10/30/2019; NC9056B Exp. 11/04/2019
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 83999This product is part of a recall event; the main page for the event is Amino Acid Injection (50 mg/mL) L-Arginine HCl recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Amino Acid Injection (50 mg/mL) L-Arginine HCl recalled | Nephron Pharmaceuticals | Sterility | Nationwide |
More recalls from Nephron Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS III | PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg recalled | Nephron Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS II | PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl recalled | Nephron Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl recalled | Nephron Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl recalled | Nephron Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Amino Acid Injection (50 mg/mL) L-Arginine HCl recalled | Nephron Pharmaceuticals | Sterility | Nationwide |