Neostigmine Injection Recall for Potential Cross-Contamination Due to Manufacturing Controls
Nephron Sterile Compounding Center is recalling 56,220 vials of PF-Neostigmine Methylsulfate Injection due to potential cross-contamination from manufacturing control deviations.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving potential cross-contamination due to manufacturing control deviations. No illnesses or injuries have been reported, and the hazard is theoretical and precautionary in nature.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling 56,220 vials of PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) due to Current Good Manufacturing Practice (CGMP) deviations. The company identified a potential for cross-contamination due to product carry-over during the manufacturing process.
The affected lots are: NE1062A and NE1062B (expiration 12/02/2022), NE1065A and NE1065B (expiration 12/13/2022), and NE2011A and NE2011B (expiration 03/15/2022). These vials were distributed nationwide across the United States.
Patients and healthcare providers should stop using affected vials immediately. Contact your healthcare provider or pharmacist if you have questions about whether you have received an affected product.
The recalled product
- Product
- PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Prescription Injectable
- Affected units
- 56,220
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 (6)
- Lots: NE1062A
- NE1062B Exp. 12/02/2022
- NE1065A
- NE1065B Exp. 12/13/2022
- NE2011A
- NE2011B Exp. 03/15/2022.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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