FDA recall D-0821-2020

McGuff Compounding Pharmacy Services, Inc. · Class II · drug

Product

Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704

Reason for recall

Presence of Particulate Matter: Particulates observed in vials release for dispensing.

Distribution

Prescriptions filled for patients in the following states: AK, AZ, CA, CO, DC, FL, IN, MA, MT, NC, NJ, NY, OR, SC, TX, UT, VA, WA, and WI.

Key facts

Status
Terminated
Initiation date
2019-02-14
Report date
2020-02-05
Termination date
2023-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Ana, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0821-2020