Neostigmine Methylsulfate Injection Recalled for Lack of Sterility Assurance

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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