Status
Terminated
Drug Enforcement D-952-2013
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Classification
Class II
Report Date
September 18, 2013
Termination Date
July 18, 2014
Product Information
- Product description
- 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
- Product quantity
- N/A
- Reason for recall
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- USA nationwide
Location & Firm
- Recalling firm
- Beacon Hill Medical Pharmacy, P.C.
- Address
-
18161 W 13 Mile Rd, Suite A1
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-952-2013
- Event ID
- 65876
- Recall initiation date
- July 26, 2013
- Center classification date
- September 10, 2013
- 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.
- More code info
- —