Status
Terminated
Drug Enforcement D-409-2013
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 22, 2013
Termination Date
March 21, 2014
Product Information
- Product description
- Sodium Tetradecyl Sulfate Injection, all strengths and all presentations including a) Sodium Tetradecyl Sulfate 3% 50 mL, b) Sodium Tetradecyl Sulfate 3% mL, c) Sodium Tetradecyl Sulfate-2% 30 mL, d) Sodium Tetradecyl Sulfate-2.5% 20 mL, e) Sodium Tetradecyl Sulfate 0.3% 30 mL, f) Sodium Tetradecyl Sulfate 1% 30 mL, 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Product quantity
- 203 vials
- 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
- Press Release
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Address
-
1850 Whitney Mesa Dr, Suite 180
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-409-2013
- Event ID
- 64879
- Recall initiation date
- April 10, 2013
- Center classification date
- May 16, 2013
- Code info
- Lot #: a) Sodium Tetradecyl 3% 50 mL: 20130318-G, Exp 6/18/2013; b) Sodium Tetradecyl 3% mL: 20130218-G, Exp 5/18/2013; c) Sodium Tetradecyl-2% 30 mL: 20130122-B, Exp 4/22/2013; d) Sodium Tetradecyl-2.5% 20 mL: 20130114-D, Exp 4/14/2013; 20130117-C, Exp 4/17/2013 .
- More code info
- —