FDA recall D-0802-2020

Product

Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704

Reason for recall

Presence of Particulate Matter: filmy/cloudy particulate observed in vial.

Distribution

Distributed Nationwide in the US

Key facts

Status

Terminated

Initiation date

2019-01-10

Report date

2020-01-22

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-0802-2020