Agency classClass IIOur severity:High FDA (Drugs)·D-1272-2022·Announced 2022-07-27

Neostigmine Methylsulfate Injection Recalled for Lack of Sterility Assurance

Nephron Sterile Compounding Center is recalling 64,365 syringes of Neostigmine Methylsulfate Injection nationwide due to lack of assurance of sterility. Patients using affected lots should contact their healthcare provider.

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 3/5 (High).

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: FDA Class II recall for lack of sterility assurance in injectable pharmaceutical. No reported illnesses or adverse events. Classified as risk-of-harm product where potential injury has not yet been reported.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling 64,365 pre-filled syringes of Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) due to lack of assurance of sterility. The affected lots are NE2005A (expiration 7/23/2022), NE2012A (expiration 10/3/2022), NE2012B (expiration 10/3/2022), and NE2012C (expiration 10/3/2022). The product was distributed nationwide through the manufacturer's 503B outsourcing facility in West Columbia, South Carolina.

Sterile injectable drugs must meet strict sterility standards. The lack of assurance of sterility means these product lots may not be safe for use as intended.

Patients who have received or may have received syringes from the affected lots should contact their healthcare provider. Healthcare providers should not use the recalled product. Patients and healthcare providers can report any adverse events to the FDA's MedWatch program or contact Nephron Sterile Compounding Center LLC.

The recalled product

Product: Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 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: 69374-902-05
Manufacturer: Nephron Sterile Compounding Center LLC
Category: Drug — Injectable / Compounded
Hazard: lack-of-sterility
contamination-risk
Affected units: 64,365

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: NE2005A
Exp. 7/23/2022
NE2012A
Exp. 10/3/2022
NE2012B
NE2012C

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 →

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · lack of sterility