D-1113-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 6, 2023
- Initiation Date
- August 17, 2023
- Termination Date
- March 27, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3519 Syringes
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
Distribution Pattern
Nationwide in the USA
Code Information
Lot# 36-262729, 36-262982, 36-262981, 36-262732, 36-262731, 36-262730, Exp 10/11/2023 ;