PlainRecalls
FDA Drug Moderate Class II Terminated

fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,

Reported: April 3, 2024 Initiated: November 9, 2023 #D-0403-2024

Product Description

fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,

Reason for Recall

Lack of Assurance of Sterility

Details

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

Frequently Asked Questions

What product was recalled?
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,. Recalled by SCA Pharmaceuticals, LLC. Units affected: 500 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-0403-2024.