D-380-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2013
- Initiation Date
- April 10, 2013
- Termination Date
- March 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 209 vials
Product Description
Lipotropic With Vitamin Injections, all strengths and all presentations including a) Lipo W/ Vitamin 100 mL, b) Lipo W/ Vitamins 30 mL, c) Lipo W/Vitamin, d) Lipo w/Vitamins #5 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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.
Distribution Pattern
Nationwide
Code Information
Lot #: a) Lipo W/ Vitamin 100 mL: 20130322-D, Exp 6/22/2013; 20130115-H, Exp 4/15/2013; b) Lipo W/ Vitamins 30 mL: 20130228-H, Exp 5/28/2013; 20130228-H, Exp 5/28/2013; 20130322-D, Exp 6/22/2013; 20130208-J, Exp 5/8/2013; c) Lipo W/Vitamin: 20130228-H, Exp 5/28/2013; d) Lipo w/Vitamins #5 30 mL: 201301281000IN, Exp 4/28/2013