D-405-2014 Class II Terminated
FDA drug recall D-405-2014 was initiated by Compounding Centre At Blue Ridge on October 18, 2013 and is designated Class II. 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 contr… The recall status is terminated (terminated April 19, 2017).
Recall Details
- Product Type
- Drugs
- Report Date
- January 15, 2014
- Initiation Date
- October 18, 2013
- Termination Date
- April 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
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.
Distribution Pattern
NC
Code Information
All Lots