PlainRecalls
FDA Drug Moderate Class II Terminated

Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159

Reported: April 3, 2024 Initiated: November 9, 2023 #D-0412-2024

Product Description

Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
SCA Pharmaceuticals, LLC
Units Affected
1,508 bags; expanded 1,015 bags
Distribution
Nationwide in the USA
Location
Windsor, CT

Frequently Asked Questions

What product was recalled?
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159. Recalled by SCA Pharmaceuticals, LLC. Units affected: 1,508 bags; expanded 1,015 bags.
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-0412-2024.