PlainRecalls
FDA Drug Moderate Class II Terminated

Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05

Reported: June 8, 2022 Initiated: May 18, 2022 #D-0963-2022

Product Description

Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
64450 syringes
Distribution
Nationwide in the USA
Location
West Columbia, SC

Frequently Asked Questions

What product was recalled?
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 64450 syringes.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on June 8, 2022. Severity: Moderate. Recall number: D-0963-2022.