RecallRadar

FDA Drug recall D-1271-2022

Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe C…

On 2022-07-27 the FDA classified a Class II recall of Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe C… by Nephron Sterile Compounding Center, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1271-2022
ClassificationClass II
Statusterminated
Initiated2022-06-30
Published2022-07-27
Last updated2026-09-13 11:52 UTC
CompanyNephron Sterile Compounding Center
DistributionUS

Product

Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 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: 69374-942-04

Reason

Lack of Assurance of Sterility

Identifiers

code_infoLots: NE2004A, Exp. 7/26/2022; NE2010A, Exp. 9/5/2022; NE2013A, Exp. 10/20/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1271-2022%22

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