FDAClass IIApril 30, 2025

Rocuronium Bromide 50 mg per recall: Sterility Concern

Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC…

Why was Rocuronium Bromide 50 mg per recalled?

Lack of Assurance of Sterility: Leaking/damaged syringes.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 #:2530023, Exp.: 7/12/2025

Product
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC…
Recalling firm
Denver Solutions, LLC DBA Leiters Health
Quantity
16,655 syringes
Distribution
Nationwide in the U.S.A
Recall date
April 30, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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