Why it was recalled
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Product description
Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.
Lot numbers, UPCs & expiration codes
Lot: 22K1681, initial BUD: 12/18/2022, extended BUD: 1/27/2023.
Where it was sold
Nationwide in the USA
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-0266-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 8, 2022
- FDA report date
- Feb 22, 2023
- Quantity
- 11 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- McGuff Compounding Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0266-2023, exactly as published.
Show all FDA fields
- City
- Santa Ana
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 91498
- Address
- 2921 W Macarthur Blvd Ste 142
- Code information
- Lot: 22K1681, initial BUD: 12/18/2022, extended BUD: 1/27/2023.
- Postal code
- 92704-7944
- Report date
- Feb 22, 2023
- Product type
- Drugs
- Recall number
- D-0266-2023
- Classification
- Class II
- Recalling firm
- McGuff Compounding Pharmacy Services, Inc.
- Product quantity
- 11 vials
- Termination date
- Apr 27, 2023
- Reason for recall
- Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 8, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 10, 2023