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Safety Updates

American Regent is dedicated to ensuring the safe use of our products. Below you will find product-specific safety notifications. If you have additional questions, please contact our Drug Information Support Group.

Drug Information

Phone: 888-354-4855 (9am-5pm Eastern Time, Monday-Friday)

For drug information outside of normal business hours that cannot wait until the next day, please call 877-845-6371



10 Jan 2024

Subject: PROVAYBLUE® (methylene blue) injection USP, for intravenous use 

  • Serotonin Syndrome with concomitant use of Serotonergic drugs (drugs producing serotonergic effects) and Opioids

Dear Health Care Provider:

This letter aims to inform you of important safety information for PROVAYBLUE® (methylene blue 0.5%) injection USP, approved for treating pediatric and adult patients with acquired methemoglobinemia.

Serious risks with concomitant use of PROVAYBLUE® and Serotonergic drugs, and Opioids.
Provayblue® (methylene blue 0.5%) injection is a reversible monoamine oxidase inhibitor (MAOI). As indicated in its Black Box Warning, concomitant use of methylene blue and serotonergic drugs and opioids has the potential for a serious or fatal serotonergic syndrome.

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Re: ProvayBlue® (methylene blue) injection, USP — Potential Medication Errors Associated with Improper Preparation

4 Apr 2022

Dear Healthcare Professional,

American Regent, Inc., would like to reinforce the appropriate preparation of ProvayBlue® (methylene blue) Injection, USP using a solution of 50 mL 5% Dextrose Injection.

ProvayBlue® is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.

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Caffeine and Sodium Benzoate Injection, USP, 250 mg/mL (125 mg/mL Caffeine) 2 mL Single Dose Vials NDC# 0517-2502-10

1 Apr 2019

All lots of Caffeine and Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vials,
manufactured and distributed by American Regent, Inc. in commercial distribution may exhibit
evidence of visible or sub-visible particles.

Internal procedures are in place to detect visible particles that may be present in Caffeine and Sodium
Benzoate Injection, USP, prior to release. Each lot is 100% inspected by automated inspection
machinery that is designed to detect visible particles. In addition to automated inspection, samples of
filled product are visually examined by Quality Assurance as part of normal lot release procedures. All
lots that have been released for distribution have been inspected in this manner, and have met all release
specifications for particulates. However, there is a potential for the transient appearance of particles
that represent trace amounts of the product’s active ingredient.

As a precautionary measure, a filter must be used for the withdrawal and administration of all
lots of Caffeine and Sodium Benzoate Injection, USP.

Read the Full Safety Update