Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmac...

FDA Recall #D-0830-2022 — Class II — April 25, 2022

Recall #D-0830-2022 Date: April 25, 2022 Classification: Class II Status: Terminated

Product Description

Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32

Reason for Recall

CGMP Deviations

Recalling Firm

SCA Pharmaceuticals — Windsor, CT

Classification

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

Product Type

Drugs

Product Quantity

424 bags

Distribution

Product was distributed nationwide within the United States

Code Information

Lot #: 1222035837, Exp. Date 22-Jul-22 Lot #: 1222035804, Exp. Date 25-Jul-22

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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