Nephron Recalls del Nido Cardioplegia Solution Due to Sterility Concerns
Nephron Pharmaceuticals is recalling 1,047 bags of del Nido Cardioplegia Solution because the bags may leak, compromising sterility.
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, which corresponds to a Severe severity score under the rubric, particularly given the risk of sterility failure in a sterile injectable solution.
Plain-English summary
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center is recalling 1,047 bags of del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container. The recall was initiated due to a lack of assurance of sterility, as the bags have the potential to leak.
The affected product is distributed nationwide. The recall includes specific lots with expiration dates ranging from October 14, 2019, to November 4, 2019. The product is a prescription-only medication used in cardiac surgery.
Healthcare facilities and consumers should stop using the affected product and contact Nephron Pharmaceuticals for further instructions or a return.
The recalled product
- Product
- 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
- Category
- Drug — Sterile Compounded Drug
- Hazard
- Affected units
- 1,047
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 (14)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center 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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