Status
Terminated
Drug Enforcement D-0267-2023
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Classification
Class II
Report Date
February 22, 2023
Termination Date
April 27, 2023
Product Information
- Product description
- Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.
- Product quantity
- 255 vials
- Reason for recall
- Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- McGuff Compounding Pharmacy Services, Inc.
- Address
-
2921 W Macarthur Blvd Ste 142, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0267-2023
- Event ID
- 91498
- Recall initiation date
- December 8, 2022
- Center classification date
- February 10, 2023
- Code info
- Lot: 22K1661, initial BUD: 12/18/2022, extended BUD: 1/27/2023; 22J2401, BUD: 12/19/2022.
- More code info
- —