FDAClass IISeptember 6, 2023

rocuronium 50 mg/5 mL recall: Sterility Concern

rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.

Why was rocuronium 50 mg/5 mL recalled?

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

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# 36-262729, 36-262982, 36-262981, 36-262732, 36-262731, 36-262730, Exp 10/11/2023 ;

Product
rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
Recalling firm
Central Admixture Pharmacy Services, Inc.
Quantity
3519 Syringes
Distribution
Nationwide in the USA
Recall date
September 6, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls