Status
Terminated
Drug Enforcement D-292-2013
Lack of Sterility Assurance
Classification
Class II
Report Date
May 1, 2013
Termination Date
April 19, 2017
Product Information
- Product description
- HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
- Product quantity
- 1 vial (10 mL)
- Reason for recall
- Lack of Sterility Assurance
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- CO, GA, MI, and Puerto Rico
Location & Firm
- Recalling firm
- Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Address
-
550 Technology Park Ste 1008
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-292-2013
- Event ID
- 64957
- Recall initiation date
- April 17, 2013
- Center classification date
- April 23, 2013
- Code info
- ALL Lots
- More code info
- —