FDAClass IINovember 18, 2020

Bupivacaine Hydrochloride in 8.25% Dextrose Injection recall: Particulate Matter

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…

Why was Bupivacaine Hydrochloride in 8.25% Dextrose Injection recalled?

Presence of particulate matter in solution - black and transparent particles

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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…
Recalling firm
Baxter Healthcare Corporation
Distribution
Nationwide USA
Recall date
November 18, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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