CLASS II Drug recall · Reported 22 Jan 2020 · FDA Enforcement Report
Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic recalled
McGuff Compounding Pharmacy Services is recalling Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/ (40 mg/mL), distributed nationwide in the US. The recall was initiated on 10 Jan 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0802-2020
- FDA event ID
- 84618
- Recalling firm
- McGuff Compounding Pharmacy Services, Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2019
- FDA classified
- 29 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Jan 2019 | Recall initiated by company | |
| 22 Jan 2020 | Published in enforcement report | +377 days |
| 29 Jan 2020 | Classified by FDA | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the US
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Which lots are affected?
Lot #: 18M0991, Preparation #: 390-2678, Beyond Usage Date: 06/15/2019
Where was it sold?
Distributed Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from McGuff Compounding Pharmacy Services
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Thiamine Hydrochloride 3000 mg/ (100mg/mL) recalled | McGuff Compounding Pharmacy Services | Particulate Matter | Nationwide |
| Drug | CLASS II | Thiamine Hydrochloride 200 mg/ (100mg/mL), Riboflavin 2 mg recalled | McGuff Compounding Pharmacy Services | Particulate Matter | Nationwide |
| Drug | CLASS II | Dimercaptopropanesulfonate Sodium (DMPS) recalled | McGuff Compounding Pharmacy Services | Particulate Matter | 19 states |