PlainRecalls
FDA Drug Moderate Class II Terminated

neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009

Reported: April 3, 2024 Initiated: November 9, 2023 #D-0413-2024

Product Description

neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
SCA Pharmaceuticals, LLC
Units Affected
1,122 syringes
Distribution
Nationwide in the USA
Location
Windsor, CT

Frequently Asked Questions

What product was recalled?
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009. Recalled by SCA Pharmaceuticals, LLC. Units affected: 1,122 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 April 3, 2024. Severity: Moderate. Recall number: D-0413-2024.