Recalls / Class II
Class IID-952-2013
Product
DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, 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
- 05302013@6, 02112013@5, 04192013@21, 05032013@14, 01252013@11, 03272013@17, 01252013@8, 03272013@22, 01312013@9, 06062013@24, 01032013@1, 01152013@14, 01292013@4, 01312013@10, 02142013@9, 03062013@10, 03112013@6, 03112013@4, 04042013@16, 04122013@18, 04302013@24, 05102013@18, 05282013@29, 06042013@18, 06282013@10, 07112013@21, 07232013@1, 07282013@1, 07282013@2, 01312013@8, 05222013@26.
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-952-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.