Recalls / Class II
Class IID-401-2014
Product
Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
- Affected lot / code info
- All Lots
Why it was recalled
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.
Recalling firm
- Firm
- Compounding Centre At Blue Ridge
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 2601 Blue Ridge Rd, Raleigh, North Carolina 27607-6481
Distribution
- Quantity
- 92 units
- Distribution pattern
- NC
Timeline
- Recall initiated
- 2013-10-18
- FDA classified
- 2014-01-09
- Posted by FDA
- 2014-01-15
- Terminated
- 2017-04-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-401-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.