FDA recall D-0654-2022

Golden State Medical Supply Inc. · Class II · drug

Product

Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.

Reason for recall

CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.

Distribution

Distributed to 1 wholesaler/distributor

Key facts

Status: Terminated
Initiation date: 2022-03-02
Report date: 2022-03-23
Termination date: 2022-09-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0654-2022