Why it was recalled
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 18M0991, Preparation #: 390-2678, Beyond Usage Date: 06/15/2019
Where it was sold
Distributed Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0802-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 10, 2019
- FDA report date
- Jan 22, 2020
- Quantity
- 146 30 ml vials were dispensed
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- McGuff Compounding Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0802-2020, exactly as published.
Show all FDA fields
- City
- Santa Ana
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84618
- Address
- 2921 W Macarthur Blvd Ste 142
- Code information
- Lot #: 18M0991, Preparation #: 390-2678, Beyond Usage Date: 06/15/2019
- Postal code
- 92704-7944
- Report date
- Jan 22, 2020
- Product type
- Drugs
- Recall number
- D-0802-2020
- Classification
- Class II
- Recalling firm
- McGuff Compounding Pharmacy Services, Inc.
- Product quantity
- 146 30 ml vials were dispensed
- Termination date
- Nov 20, 2023
- Reason for recall
- Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the US
- Recall initiation date
- Jan 10, 2019
- Initial firm notification
- Telephone
- Center classification date
- Jan 29, 2020