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

FDA recall notice · announced January 22, 2020 · Mcguff Compounding Pharmacy Services

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Distributed Nationwide in the US
Lot/code information: Lot #: 18M0991, Preparation #: 390-2678, Beyond Usage Date: 06/15/2019
Quantity: 146 30 ml vials were dispensed
Status: Terminated
Products in this recall event:
- 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 (D-0802-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.