FDA Drug recall D-0802-2020
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…
- FDA Drug
- Class II
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class II recall of 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… by Mcguff Compounding Pharmacy Services, citing presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0802-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-10 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mcguff Compounding Pharmacy Services |
| Distribution | US |
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
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Identifiers
| code_info | Lot #: 18M0991, Preparation #: 390-2678, Beyond Usage Date: 06/15/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0802-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.