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Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR I...

FDA Recall #D-0267-2023 — Class II — December 8, 2022

Recall #D-0267-2023 Date: December 8, 2022 Classification: Class II Status: Terminated

Product Description

Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.

Reason for Recall

Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.

Recalling Firm

McGuff Compounding Pharmacy Services, Inc. — Santa Ana, CA

Classification

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

Product Type

Drugs

Product Quantity

255 vials

Distribution

Nationwide in the USA

Code Information

Lot: 22K1661, initial BUD: 12/18/2022, extended BUD: 1/27/2023; 22J2401, BUD: 12/19/2022.

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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