Drug 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
D-0802-2020
Product summary
- Event
- Event 84618
- Status
- Terminated
- Classification
- Class II
- Quantity
- 146 30 ml vials were dispensed
- Official record key
drug-enforcement:D-0802-2020
Official wording
Reason: Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Code information: Lot #: 18M0991, Preparation #: 390-2678, Beyond Usage Date: 06/15/2019
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter