Home / Recalls / SCA Pharmaceuticals, LLC / D-0397-2024

D-0397-2024 Class II Terminated

Recalled by SCA Pharmaceuticals, LLC — Windsor, CT

FDA drug recall D-0397-2024 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: 242 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: 242 bags

Product Description

fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 1223048855, Exp 12/6/23

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0397-2024
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.

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