rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2...
FDA Recall #D-1113-2023 — Class II — August 17, 2023
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3519 Syringes
Distribution
Nationwide in the USA
Code Information
Lot# 36-262729, 36-262982, 36-262981, 36-262732, 36-262731, 36-262730, Exp 10/11/2023 ;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated