FDAClass IINovember 23, 2022

PF-Neostigmine Methylsulfate Injection recall: CGMP Deviations

PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West…

Why was PF-Neostigmine Methylsulfate Injection recalled?

CGMP Deviations: Potential for cross contamination due to product carry over.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: NE1062A, NE1062B Exp. 12/02/2022; NE1065A, NE1065B Exp. 12/13/2022; NE2011A, NE2011B Exp. 03/15/2022.

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…
Recalling firm
Nephron Sterile Compounding Center LLC
Quantity
56,220 vials
Distribution
Nationwide in the USA
Recall date
November 23, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls