Status
Terminated
Drug Enforcement D-405-2014
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Classification
Class II
Report Date
January 15, 2014
Termination Date
April 19, 2017
Product Information
- Product description
- Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
- Product quantity
- —
- Reason for recall
- Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- NC
Location & Firm
- Recalling firm
- Compounding Centre At Blue Ridge
- Address
-
2601 Blue Ridge Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-405-2014
- Event ID
- 66568
- Recall initiation date
- October 18, 2013
- Center classification date
- January 9, 2014
- Code info
- All Lots
- More code info
- —