PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: September 6, 2023 Initiated: August 17, 2023 #D-1113-2023

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

Details

Units Affected
3519 Syringes
Distribution
Nationwide in the USA
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 3519 Syringes.
Why was this product recalled?
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Which agency issued this recall?
This recall was issued by the FDA Drug on September 6, 2023. Severity: Moderate. Recall number: D-1113-2023.