Recalls / Class II
Class IID-941-2013
Product
BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML and BI-MIX PHENTOLAMINE/PAPAVERINE 1 MG/30 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Affected lot / code info
- 07232013@23 and 04232013@27
Why it was recalled
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recalling firm
- Firm
- Beacon Hill Medical Pharmacy, P.C.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 18161 W 13 Mile Rd, Suite A1, Southfield, Michigan 48076-1113
Distribution
- Quantity
- N/A
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2013-07-26
- FDA classified
- 2013-09-10
- Posted by FDA
- 2013-09-18
- Terminated
- 2014-07-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-941-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.