The Recall Desk
HighFDA (Drugs)·D-1270-2022·Announced 2022-07-27

Neostigmine Methylsulfate Injection Recalled Due to Lack of Sterility Assurance

Nephron Sterile Compounding Center LLC is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The recall affects 59,520 syringes distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II FDA recall for a sterile injectable medication where assurance of sterility cannot be provided. No illnesses or deaths have been reported, but the loss of sterility assurance in a critical-care injectable presents a risk of harm.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) pre-filled syringes. This is a prescription-only medication. The recall was issued due to lack of assurance of sterility and affects 59,520 syringes distributed nationwide.

This is classified as an FDA Class II recall. The affected lot numbers are NE2002A (Exp. 7/14/2022), NE2003A (Exp. 7/24/2022), NE2006A (Exp. 8/1/2022), NE2007A (Exp. 8/9/2022), NE2008A (Exp. 8/18/2022), NE2009A (Exp. 8/27/2022), and NE2012D (Exp. 10/3/2022).

The recalled product

Product
Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-932-03
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable Compounded
Hazard
Affected units
59,520

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:NE2002A
  • Exp. 7/14/2022
  • NE2003A
  • Exp. 7/24/2022
  • NE2006A
  • Exp. 8/1/2022
  • NE2007A
  • Exp. 8/9/2022
  • NE2008A
  • Exp. 8/18/2022
  • NE2009A
  • Exp. 8/27/2022
  • NE2012D
  • Exp. 10/3/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 37 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.

See all 37 products in this recall →

Related recalls

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · lack of sterility

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