RecallRadar

FDA Drug recall D-0203-2021

neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095,…

On 2021-01-13 the FDA classified a Class II recall of neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095,… by Sca Pharmaceuticals, citing lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0203-2021
ClassificationClass II
Statusterminated
Initiated2020-12-17
Published2021-01-13
Last updated2026-09-13 11:52 UTC
CompanySca Pharmaceuticals
DistributionUS

Product

neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009

Reason

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

Identifiers

code_infoLot # 1220023044, BUD 1/30/2021

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-0203-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.