FDA recall D-0982-2023

Central Admixture Pharmacy Services, Inc. · Class II · drug

Product

neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6065-1

Reason for recall

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2023-07-14
Report date
2023-08-09
Termination date
2025-03-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0982-2023