Home / Recalls / SCA Pharmaceuticals, LLC / D-0419-2024

D-0419-2024 Class II Terminated

Recalled by SCA Pharmaceuticals, LLC — Windsor, CT

FDA drug recall D-0419-2024 was initiated by SCA Pharmaceuticals, LLC on Nov 9, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Aug 27, 2024). Affected quantity: 400 bags.

Recall Details

Product Type: Drugs
Report Date: Apr 3, 2024
Initiation Date: Nov 9, 2023
Termination Date: Aug 27, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 400 bags

Product Description

PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 1223050005 Exp 01/13/24

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0419-2024
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by SCA Pharmaceuticals, LLC

D-0417-2024 Class II — PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection… (Nov 9, 2023)
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D-0396-2024 Class II — fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE… (Nov 9, 2023)
D-0414-2024 Class II — PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection… (Nov 9, 2023)
D-0405-2024 Class II — HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration =… (Nov 9, 2023)
D-0401-2024 Class II — fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL… (Nov 9, 2023)
D-0410-2024 Class II — HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration… (Nov 9, 2023)
D-0416-2024 Class II — PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration… (Nov 9, 2023)
D-0400-2024 Class II — fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL… (Nov 9, 2023)
D-0423-2024 Class II — SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL… (Nov 9, 2023)