FDA recall D-0159-2016

Chen Shwezin, Inc. dba Park Compounding Pharmacy · Class II · drug

Product

CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258

Reason for recall

Lack of Assurance of Sterility: all sterile compounded products within expiry

Distribution

CA

Key facts

Status
Terminated
Initiation date
2015-10-06
Report date
2015-11-04
Termination date
2015-11-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Westlake Village, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0159-2016