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Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL si...

FDA Recall #D-0076-2021 — Class II — October 7, 2020

Recall #D-0076-2021 Date: October 7, 2020 Classification: Class II Status: Terminated

Product Description

Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10

Reason for Recall

Presence of particulate matter in solution - black and transparent particles

Recalling Firm

Baxter Healthcare Corporation — Deerfield, IL

Classification

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

Product Type

Drugs

Distribution

Nationwide USA

Code Information

Lot #: A0B1241, Exp 10/2020; A0C0091, Exp 12/2020; A0D0268, Exp 02/2022

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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