D-395-2013 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
- 588 vials and syringes
Product Description
MIC Vitamin Injection, all strengths and all presentations including a) MIC 25-50-25-30 mL, b) MIC_B_COMP-B12-25-50-50-1000-30 mL, c) MIC_B12-25-50-25-400-30 mL, d) MIC_B6_B12-30 mL, e) MIC_METH_VIT-#3-30 m, f) MIC_METH-25-50-50-1000 mcg 30 mL, g) MIC_ULTRA-30 mL, h) MIC_VIT_METH_CARN-12.5-25-25-1-25-30 mL, i) MIC-25-50-25 Cyano 1000 mcg/mL 30 mL, j) MIC-25-50-50-30 mL, k) MIC-8-15-15-30, l) MIC-B12-30, 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) MIC 25-50-25-30 mL: 20130130-D, Exp 4/30/2013; 20130214-F, Exp 5/14/2013; b) MIC_B_COMP-B12-25-50-50-1000-30 mL: 1303261000AE, Exp 6/26/2013; c) MIC_B12-25-50-25-400-30 mL: 20130307-I, Exp 6/7/2013; 20120206-H, Exp 5/6/2013; d) MIC_B6_B12-30 mL: 20130208-E, Exp 5/8/2013; e) MIC_METH_VIT-#3-30 mL: 1302072000AE, Exp 5/7/2013; f) MIC_METH-25-50-50-1000 mcg 30 mL: 20130326-G, Exp 6/26/2013; g) MIC_ULTRA-30 mL: 20130220-I, Exp 5/20/2013; h) MIC_VIT_METH_CARN-12.5-25-25-1-25-30 mL: 1302081000AE, Exp 5/8/2013; 20130327-C, Exp 6/27/2013; i) MIC-25-50-25 Cyano 1000 mcg/mL 30mL: 1303261000AE, Exp 6/26/2013; j) MIC-25-50-50-30 mL; 20130213-E, Exp 5/13/2013; k) MIC-8-15-15-30: 20130118-C, Exp 4/18/2013; 20130318-F, Exp 6/18/2013; l) MIC-B12-30: 20130114-C, Exp 4/14/2013