Status
Terminated
Drug Enforcement D-1010-2013
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
- VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, 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-1010-2013
- Event ID
- 65876
- Recall initiation date
- July 26, 2013
- Center classification date
- September 10, 2013
- Code info
- 03082013@20, 07032013@15
- More code info
- —