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fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL...

FDA Recall #D-0400-2024 — Class II — November 9, 2023

Recall #D-0400-2024 Date: November 9, 2023 Classification: Class II Status: Terminated

Product Description

fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

SCA Pharmaceuticals, LLC — Windsor, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

412 cassettes

Distribution

Nationwide in the USA

Code Information

Lot #: 1223049261, Exp 12/25/23; 1223049724, Exp 01/11/24

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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