Status
Terminated
Drug Enforcement D-572-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Classification
Class II
Report Date
June 12, 2013
Termination Date
September 30, 2024
Product Information
- Product description
- Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
- Product quantity
- 4 vials of 5mL and 22 vials of 10mL
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Florida, California, Minnesota, and Maine
Location & Firm
- Recalling firm
- THE COMPOUNDING SHOP, INC.
- Address
-
4000 Park St N, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-572-2013
- Event ID
- 65125
- Recall initiation date
- May 2, 2013
- Center classification date
- June 4, 2013
- Code info
- All Lots
- More code info
- —