Status
Terminated
Drug Enforcement D-293-2013
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Classification
Class II
Report Date
May 1, 2013
Termination Date
April 19, 2017
Product Information
- Product description
- Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
- Product quantity
- 5 vials (30 mL each)
- Reason for recall
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- 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-293-2013
- Event ID
- 64957
- Recall initiation date
- April 17, 2013
- Center classification date
- April 23, 2013
- Code info
- ALL Lots
- More code info
- —