PlainRecalls
FDA Drug Moderate Class II Terminated

rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.

Reported: August 9, 2023 Initiated: July 14, 2023 #D-0947-2023

Product Description

rocuronium50 mg/5 mL (10 mg/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. Validation data for decontamination cycles is lacking.

Details

Units Affected
77,554 Syringes.
Distribution
Nationwide in the USA
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
rocuronium50 mg/5 mL (10 mg/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: 77,554 Syringes..
Why was this product recalled?
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 9, 2023. Severity: Moderate. Recall number: D-0947-2023.