Multi-event April 2013 FDA Recall Drug by Fvs Holdings, Inc. Dba. Green Valley Drugs

This Multi-event Class II drug recall was voluntarily initiated by Fvs Holdings, Inc. Dba. Green Valley Drugs on April 10, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-358-2013 TERMINATED D-384-2013 TERMINATED D-389-2013 TERMINATED D-370-2013 TERMINATED D-391-2013 TERMINATED D-350-2013 TERMINATED D-381-2013 TERMINATED D-380-2013 TERMINATED D-355-2013 TERMINATED D-349-2013 TERMINATED D-342-2013 TERMINATED D-410-2013 TERMINATED D-403-2013 TERMINATED D-372-2013 TERMINATED D-345-2013 TERMINATED D-388-2013 TERMINATED D-357-2013 TERMINATED D-352-2013 TERMINATED D-395-2013 TERMINATED D-400-2013 TERMINATED D-396-2013 TERMINATED D-387-2013 TERMINATED D-368-2013 TERMINATED D-360-2013 TERMINATED D-411-2013 TERMINATED D-353-2013 TERMINATED D-373-2013 TERMINATED D-398-2013 TERMINATED D-382-2013 TERMINATED D-348-2013 TERMINATED D-416-2013 TERMINATED D-377-2013 TERMINATED D-394-2013 TERMINATED D-344-2013 TERMINATED D-386-2013 TERMINATED D-374-2013 TERMINATED D-362-2013 TERMINATED D-397-2013 TERMINATED D-343-2013 TERMINATED D-359-2013 TERMINATED D-371-2013 TERMINATED D-365-2013 TERMINATED D-412-2013 TERMINATED D-376-2013 TERMINATED D-378-2013 TERMINATED D-408-2013 TERMINATED D-347-2013 TERMINATED D-341-2013 TERMINATED D-367-2013 TERMINATED D-393-2013 TERMINATED D-351-2013 TERMINATED D-414-2013 TERMINATED D-346-2013 TERMINATED D-406-2013 TERMINATED D-401-2013 TERMINATED D-369-2013 TERMINATED D-390-2013 TERMINATED D-361-2013 TERMINATED D-364-2013 TERMINATED D-340-2013 TERMINATED D-399-2013 TERMINATED D-385-2013 TERMINATED D-383-2013 TERMINATED D-375-2013 TERMINATED D-356-2013 TERMINATED D-409-2013 TERMINATED D-354-2013 TERMINATED D-379-2013 TERMINATED D-413-2013 TERMINATED D-402-2013 TERMINATED D-366-2013 TERMINATED D-363-2013 TERMINATED D-405-2013 TERMINATED D-415-2013 TERMINATED D-339-2013 TERMINATED D-392-2013 TERMINATED D-404-2013 TERMINATED D-407-2013 TERMINATED

Recall Number: D-358-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
273 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/mL 10 mL P.F.; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130212-A, Exp 5/12/2013; 20130122-E, Exp 4/22/2013; 20130212-D, Exp 5/12/2013

Recall Number: D-384-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
529 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Magnesium Sulfate Injection, all strengths and all presentations including a) Magnesium Sulfate 50%; b) MAGNESIUM SULFATE 50% 50 mL, c) Magnesium Sulfate PF 50% 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Magnesium Sulfate 50%: 20130130-F, Exp 4/30/2013; 20130128-F, Exp 4/28/2013; 20130221-T, Exp 5/21/2013; b) MAGNESIUM SULFATE 50% 50 mL: 20130322-E, Exp 6/22/2013; 20130219-C, Exp 5/19/2013; 20130307-A, Exp 6/7/2013; 20130404-G, Exp 7/4/2013; c) Magnesium Sulfate PF 50% 2 mL: 20130227-F, Exp 5/27/2013; 20130312-G, Exp 6/12/2013

Recall Number: D-389-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
430 vials and syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Methylprednisolone and Dexamethasone Injection, all strengths and all presentations including a) Methylpred/ Dexameth 1-2-3 mL and b) Methylpred/Dexa 3 mL PFS; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Methylpred/ Dexameth 1-2-3 mL: 13040150GV1, Exp 7/1/2013; 13032750GV3, Exp 6/27/2013; b) Methylpred/Dexa 3 mL PFS: 13032050GV4, Exp 6/20/2013

Recall Number: D-370-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
5255 vials and syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG 1500u/1.5 mL Pre-Filled Syringe, g) HCG 5000 unit/5 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) HCG 1000u/mL: 20130319-E, Exp 5/19/2013; b) HCG 1000u/mL 10mL: 20130221-J, Exp 4/21/2013

Recall Number: D-391-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
720 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Methylprednisolone, Lidocaine, and Sodium Chloride Injection, all strengths and all presentations including a) Methylpred-Lido-Nacl-1-5-6-12 syringe and b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Methylpred-Lido-Nacl-1-5-6-12 syringe: 20120226-GV3, Exp 5/26/2013; 13012370GV3, Exp 4/23/2013; 13012480, Exp 4/24/2013; 13011550, Exp 4/15/2013; b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr: 13012370-GV3, Exp 4/23/2013

Recall Number: D-350-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
7 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Biotin Injection, all strengths and all presentations including Biotin-15-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 130117500AE, Exp 4/17/2013

Recall Number: D-381-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
176 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all presentations including a) Lipo w/Vitamins-methylcobalamin 100 mL, 30 mL, and b) Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Lipo w/Vitamins-methylcobalamin 100 mL: 20130225-A, Exp 5/25/2013; 20130326-D, Exp 6/26/2013

Recall Number: D-380-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
209 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration 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

Recall Number: D-355-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
6292 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Cyanocobalamin 1000mcg: 20130214-C, Exp 5/14/2013; 20130220-B, Exp 5/20/2013; 20130226-D, Exp 5/26/2013; 20130226-E, Exp 5/26/2013; 20130226-L, Exp 5/26/2013; 20130125-E, Exp 4/25/2013; 20130125-D, Exp 4/25/2013; 20130125-C, Exp 4/25/2013; 20130125-F, Exp 4/25/2013; 20130211-M, Exp 5/11/2013; 20130214-B, Exp 5/14/2013; 20130221-D, Exp 5/21/2013; 20130225-K, Exp 5/25/2013; 20130214-B, Exp 5/14/2013; 20130226-C, Exp 5/26/2013; 20130226-I, Exp 5/26/2013; 20130225-M, Exp 5/25/2013; 20130225-N, Exp 5/25/2013; 20130225-J, Exp 5/25/2013; 20130225-C, Exp 5/25/2013; 20130204-G, Exp 5/4/2013; 20130204-F, Exp 5/4/2013; b) Cyanocobalamin 1000mcg 30ml: 20130325-D, Exp 6/25/2013; 20130325-C, Exp 6/25/2013; 20130326-E, Exp 6/26/2013; 20130326-I, Exp 6/26/2013; 20130329-L, Exp 6/29/2013; 20130329-M, Exp 6/29/2013; 20130306-Q, Exp 6/6/2013; 20130308-K, Exp 6/8/2013; 20130401-O, Exp 7/1/2013; 20130401-M, Exp 7/1/2013; 20130402-C, Exp 7/2/2013; 20130402-B, Exp 7/2/2013; 20130329-K, Exp 6/29/2013; 20130308-L, Exp 6/8/2013; 20130401-N, Exp 7/1/2013; 20130402-H, Exp 7/2/2013; 20130402-D, Exp 7/2/2013; 20130402-A, Exp 7/2/2013; 20130403-A, Exp 7/3/2013; 20130318-P, Exp 6/18/2013; 20130318-O, Exp 6/18/2013; 20130318-Q, Exp 6/18/2013; 20130319-B, Exp 6/19/2013; 20130226-B, Exp 5/26/2013; 20130318-A, Exp 6/18/2013

Recall Number: D-349-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
270 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all presentations including a) Betameth combo 6 mg/mL lido 1% bup 0.5% syr; and b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Betameth combo 6mg/ml lido1% bup 0.5% syr: 13021975, Exp 5/19/2013; b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr: 13012550, Exp 4/25/2013; 130215100, Exp 5/15/2013

Recall Number: D-342-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
2682 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg/mL, b) corn source 500 mg/mL, c) tapioca 500 mg/mL, d) cassave 500; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) 20130313-M, Exp 6/13/2013; 20130306-N, Exp 6/6/2013; 20130220-E, Exp 5/20/2013; 20130222-D, Exp 5/22/2013; 20130205-B, Exp 5/5/2013; 20130205-C, Exp 5/5/2013; 20130222-F, Exp 5/22/2013; 20130315-H, Exp 6/15/2013; 20130313-L, Exp 6/16/2013; 20130306-O, Exp 6/6/2013; 20130328-A, Exp 6/28/2013; 20130404-F, Exp 7/4/2013; 20130333-B, Exp 6/30/2013; 20130301-D, Exp 6/1/2013; 20130311-H, Exp 6/11/2013; 20130328-A, Exp 6/28/2013; 20130404-D, Exp 7/4/2013; 20130404-E, Exp 7/4/2013; 20130315-G, Exp 6/15/2013; 20130322-G, Exp 6/22/2013; 20130228-D, Exp 5/28/2013; 20130205-B, Exp 5/5/2013; b) 20130315-G, Exp 6/15/2013; 20130322-G, Exp 6/22/2013; c) 1302121000AE, Exp 5/12/2013; 20130322-C, Exp 6/22/2013; 20130401-C, Exp 7/1/2013; 20130131-D, Exp 4/30/2013; 20130213-A, Exp 5/13/2013; 20130305-G, Exp 6/5/2013; 20130131-B, Exp 4/30/2013; 20130201-D, Exp 5/1/2013; 2013201-G, Exp 5/1/2013; 20130222-E, Exp 5/22/2013; 20130322-B, Exp 6/22/2013; 20130131-C, Exp 4/30/2013; 20130131-E, Exp 4/30/2013; 20130213-A, 5/13/2013; 20130201-A, Exp 5/2/2013; 20130221-T, Exp 5/21/2013; 20130311-D, Exp 6/11/2013; 20130311-C, Exp 6/11/2013; 20130311-B, Exp 6/11/2013; 20130314-A, Exp 6/14/2013; 20130314-B, Exp 6/14/2013; 20130315-D, Exp 6/15/2013; 20130304-A, Exp 6/4/2013; 20130318-L, Exp 6/18/2013; 20130325-B, Exp 6/25/2013; 20130318-M, Exp 6/18/2013; d) 20130128-C, Exp 4/28/2013; 20130124J, Exp 4/24/2013; 20130403-C, Exp 7/3/2013; 20130124-J, Exp 4/24/2013, 20130115-I, Exp 4/15/2013.

Recall Number: D-410-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
51 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate and Testosterone Propionate Injection, all strengths and all presentations including a) Testosterone cyp 200/test prop 20 mg 10 mL and b) Testosterone Cyp 200 mg/Test Prop 50 mg 10mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Testosterone cyp 200/test prop 20 mg 10 mL: 130102500AE, Exp 4/25/2013; b) Testosterone Cyp 200 mg/Test Prop 50 mg 10 mL: 20130305-1, Exp 6/5/2013

Recall Number: D-403-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
319 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Pyridoxine Hydrochloride Injection, all strengths and all presentations including Pyridoxine 100 mg/mL 30 mL, 50 mL, and 10 mL PF SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130130-J, Exp 4/30/2013; 20130225-D, Exp 5/25/2013; 20130315-I, Exp 6/15/2013

Recall Number: D-372-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
63 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Hydrochloric Acid Injection, all strengths and all presentations including a) Hydrochloric Acid 0.6%, b) Hydrochloric Acid 2%, c) Hydrochloric Acid Injection 0.06% 30 mL, d) Hydrochloric Acid 2 mg/mL Injection 30 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Hydrochloric Acid 0.6%: 20130212-H, Exp 5/12/2013; b) Hydrochloric Acid 2%: 2013012952000AE, Exp 4/29/2013 .

Recall Number: D-345-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
679 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
B-Complex Injection, all strengths and all presentations including a) B-Complex Injection 30 mL; b) B-Complex PF 2 mL; c) B-Complex Plus-100; d) B-Complex_B12_30 mL; e) B-Complex-50-Methyl-30-Lido 30 mL; f) B-CompSuper-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) B-Complex: 20130228-B, Exp 5/28/2013; 20130125-B, Exp 4/25/2013; b) B-Complex PF 2ml: 20130219-D, Exp 5/19/2013; 20130319 -J, Exp 6/19/2013; c) B-Complex Plus-100: 20130307-D, Exp 6/7/2013; 20130123-E, Exp 4/23/2013; d) B-Complex_B12_30ml: 20130212-F, Exp 5/12/2013; e) B-Complex-50-Methyl-30-Lido 30ml: 20130206-M, Exp 5/6/2013; f) B-CompSuper-30ml: 1302042000AE, Exp 5/4/2013.

Recall Number: D-388-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
607 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate and Marcaine Injection, all strengths and all presentations including a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75, b) Methylpred_Marc-0.25-0.27, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75: 130312200GV3, Exp 6/12/13; b) Methylpred_Marc-0.25-0.27: 13011536, Exp 4/15/2013; 20130226-GV2, Exp 5/26/2013; 13012335GV4, Exp 4/23/2013; 13012460GV2, Exp 4/24/2013

Recall Number: D-357-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
4399 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Dexamethasone Sodium Phosphate 10mg/1ml: 20130402-F, Exp 7/2/2013; b) Dexamethasone Sodium Phosphate 10mg/ml PF 1ml: 20130307-H, Exp 6/7/2013; c) Dexamethasone Sodium Phosphate 4mg/30ml: 20130117-B, Exp 4/17/2013; 20130326-C, Exp 6/26/2013; 20130307-E, Exp 6/7/2013; 20130221-D, Exp 5/21/2013; d) Dexamethasone-4mg/5ml P.F.: 20130328-L, Exp 6/28/2013

Recall Number: D-352-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
756 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine Parabens Free 0.5% 50 mL, and b) Bupivacaine PF 0.5% 30 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Bupivacaine PF 0.5% 30 mL SDV: 20130318-C, Exp 6/18/2013; 20130319-F, Exp 6/19/2013; b) Bupivacaine Paraben Free 0.5% 50 mL: 20130212-E, Exp 5/12/2013; 20130124-F, Exp 4/24/2013; 20130214-G, Exp 5/14/2013; 20130320-E, Exp 6/20/2013

Recall Number: D-395-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
588 vials and syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration 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

Recall Number: D-400-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
109 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Polidocanol Injection, all strengths and all presentations including a) Polidocanol 5% 30 mL, b) Polidocanol 1% 30 mL, c) Polidocanol 2% 30 mL, d) Polidocanol 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : Polidocanol 5% 30 mL: 20130319-I, Exp 6/19/2013; 20130326-H, Exp 6/26/2013; b) Polidocanol 1% 30 mL: 20130118-B, Exp 4/18/2013

Recall Number: D-396-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
70 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Modified Myers Cocktail Injection, all strengths and all presentations including a) Mod Meyer's Cocktail 37 mL and b) Modified Myers Cocktail 37 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) 20130321-E, Exp 6/21/2013; b) 20130215-F, Exp 5/15/2013

Recall Number: D-387-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
1343 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Methylcobalamin Injection, all strengths and all presentations including a) Methylcobalamin 1000 mcg/mL in 10 mL, 30 mL, 50 mL, 60 mL, b) Methylcobalamin 1000 mcg 30 mL, c) Methylcobalamin 5 mg/mL 30 mL, d) Methylcobalamin PF 1000 mcg/mL in 2 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Methylcobalamin 1000 mcg: 20130208-G, Exp 5/8/2013; 20130118-G, Exp 4/18/2013; 20130129-E, Exp 4/29/2013; 20130212-B, Exp 5/12/2013; 20130221-I , Exp 5/21/2013; 20130206-D, Exp 5/6/2013; 20130301-E, Exp 6/1/2013; 20130305-C, Exp 6/5/2013; b) Methylcobalamin 1000 mcg 30 mL: 20130308-G, Exp 6/8/2013; c) Methylcobalamin 5 mg/30 mL: 20130214-I, Exp 5/14/2013; d) Methylcobalamin PF 1000 mcg: 20130312-G, Exp 6/12/2013

Recall Number: D-368-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
1140 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Gentamicin Injection, all strengths and all presentations including a) Gentamicin 40 mg/2 mL, b) Gentamicin 40 mg/30 mL, c) Gentamicin-40-20 mL, d) Gentamicin-40 mg/mL-2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Gentamicin 40 mg/2 mL: 20130403-D, Exp 7/3/2013; 20130227-H, Exp 5/27/2013; b) Gentamicin 40 mg/30 mL: 20130204-E, Exp 5/4/2013; c) Gentamicin-40-20 mL: 20130204-E, Exp 5/4/2013; d) Gentamicin-40 mg/mL-2 mL; 20130227-A, Exp 5/27/2013

Recall Number: D-360-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Dimethyl Sulfoxide (DMSO) Injection, all strengths and all presentations including DMSO 99% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130130-L, Exp 4/30/2013; 20130306-G, Exp 6/6/2013; 20130131-L, Exp 4/30/2013

Recall Number: D-411-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
50 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Taurine Injection, all strengths and all presentations including a) Taurine 50 mg/mL, b) Taurine-50-30 mL, c) Taurine-50 mg-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : Taurine 50 mg/mL: 20130305-A, Exp 6/5/2013; Taurine-50-30 mL: 20130123-D, Exp 4/23/2013; Taurine-50mg-30 mL: 21030117-J, Exp 4/17/2013

Recall Number: D-353-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Buprenorphine Injection, all strengths and all presentations including Buprenorphine-0.3 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 130129300AEB, Exp 4/29/2013.

Recall Number: D-373-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
140 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Hydrogen Peroxide Injection, all strengths and all presentations including Hydrogen Peroxide 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130225-H, Exp 5/25/2013; 20130130-I, Exp 4/30/2013; 20130311-I, Exp 6/11/2013.

Recall Number: D-398-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
54 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Phenylephrine Injection, all strengths and all presentations including Phenylephrine 1% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130129-F, Exp 4/29/2013

Recall Number: D-382-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
132 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
L-Lysine Injection, all strengths and all presentations including a) L-Lysine_100-30 mL, b) L-Lysine_100 mg/30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) L-Lysine_100-30 mL: 130117300AE, Exp 4/17/2013; 20130118-F, Exp 4/18/2013; 20130129-G, Exp 4/29/2013; 20130131-G, Exp 4/30/2013; b) L-Lysine_100 mg/30 mL: 20130405-E, Exp 7/5/2013

Recall Number: D-348-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
65 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130405-F, Exp 7/5/2013; 20130222-A, Exp 5/22/2013; 20130405-F, Exp 7/5/2013

Recall Number: D-416-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
208 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Zinc Sulfate Injection, all strengths and all presentations including a) Zinc Sulfate 10 mg/mL 30 mL and b) Zinc Sulfate 1 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Zinc Sulfate 10 mg/30 mL: 20130404-A, Exp 7/4/2013; b) Zinc Sulfate 1 mg/10 mL: 20130206-B, Exp 5/6/2013 .

Recall Number: D-377-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
65 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
L-Carnitine Injection, all strengths and all presentations including L-Carnitine 500 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130402-G, Exp 7/2/2013; 20130129-H, Exp 4/29/2013

Recall Number: D-394-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
65 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Metoprolol Injection, all strengths and all presentations including Metoprolol 1 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130130-B, Exp 4/30/2013

Recall Number: D-344-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
597 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130122-C, Exp 4/22/2013; 20130122-D, Exp 4/22/2013; 20130319-A, Exp 6/19/2013

Recall Number: D-386-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
1299 vials and syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Medroxyprogesterone Acetate Injection, all strengths and all presentations including a) Medroxyprogesterone 150-30 mL, b) Medroxyprogesterone Acetate 150 mg/mL in 1 mL, 10 mL, 30 mL vials, c) Medroxyprogesterone Acetate 150 mg/mL PF syringe, d) Medroxyprogesterone Acetate 150 mg/mL syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Medroxyprogesterone 150-30 mL: 20130301-H, Exp 6/1/2013.

Recall Number: D-374-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
135 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin Injection, all strengths and all presentations including a) Hydroxocobalamin 1000 mcg/mL 30mL and b) Hydroxocobalamin 1000 mcg/mL 10 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Hydroxocobalamin 1000 mcg/mL 30 mL: 20130321-C, Exp 6/21/2013; 20130404-H, Exp 7/3/2013; 20130225-H, Exp 5/25/2013

Recall Number: D-362-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
227 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Edetate Calcium Disodium Injection, all strengths and all presentations including a) Edetate Calcium Disodium 300 mg/mL 100 mL, b) Edetate Calcium Disodium 300-30 mL, c) Calcium Edetate 200 mg/mL 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Edatate Calcium Disodium 300 mg/mL 100mL: 20130319-H, Exp 6/19/2013; 2010318-N, Exp 6/18/2013; b) Edetate Calcium Disodium 300-30 mL: 20130205-H, Exp 5/5/2013; 20130318-N, Exp 6/18/2013; 20130319-H, Exp 6/19/2013

Recall Number: D-397-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
43 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Nandrolone Decanoate Injection, all strengths and all presentations including a) Nandrolone Decanoate 300 mg/mL, b) Nandrolone 200 mg/mL, c) Nandrolone 250 mg/mL, d) Nandrolone 350 mg/mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Nandrolone Decanoate 300 mg/mL: 20130311-J, Exp 6/11/2013

Recall Number: D-343-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
4368 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130114-A, Exp 4/14/2013; 20130123-B, Exp 4/23/2013; 20130124-A, Exp 4/24/2013; 20130212-A, Exp 5/12/2013; 20130321-B, Exp 6/21/2013; 20130319-M, Exp 6/19/2013

Recall Number: D-359-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
251 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50 mg/5 mL, b) DMPS 50 mg/mL PF 5 mL, c) DMPS Acid 250 mg/5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) DMPS 50 mg/5 mL: 20130326-F, Exp 6/26/2013; b) DMPS 50 mg/mL PF 5 mL: 20130311-A, Exp 6/11/2013; c) DMPS Acid 250 mg/5 mL: 20130130-K, Exp 4/30/2013; 20130212-C, Exp 5/12/2013; 20130311-A, Exp 6/11/2013; 20130308-M, Exp 6/8/2013; 20130130-E, Exp 4/30/2013

Recall Number: D-371-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
996 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase 150u/mL, b) Hyaluronidase 150u/ml 1 mL PF, c) Hyaluronidase 150u/mL PF 1ml SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Hyaluronidaise 150u/mL: 20130205-G, Exp 5/5/2013; b) Hyaluronidase 150u/mL 1 mL PF: 20130321-A, Exp 6/21/2013; c) Hyaluronidase 150u/mL PF 1ml SDV: 20130313-E, Exp 6/13/2013. .

Recall Number: D-365-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
243 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Estradiol Valerate Injection, all strengths and all presentations including a) Estradiol Valerate 40-10 mL and b) Estradiol Valerate 40-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130114-B, Exp 4/14/2013

Recall Number: D-412-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all presentations including Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130122-G, Exp 4/22/2013

Recall Number: D-376-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
3289 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL 10 mL MDV, b) Ketorolac 30 mg/mL 2 mL SDV, c) Ketorolac 30 mg/mL 1 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Ketorolac 30 mg/mL 10 mL: 20130327-B, Exp 6/27/2013; b) Ketorolac 30 mg/mL 2 mL: 20130326-B, Exp 6/26/2013; 20130307-C, Exp 6/7/2013

Recall Number: D-378-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
430 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) L-Glut-100 mg-30 mL: 20130213-D, Exp 5/13/2013; b) L-Glut-200 mg/30 mL: 20130318-J, Exp 6/18/2013; 20130301-C, Exp 6/1/2013 ; d) L-Glutathione-200-30 mL, 30 mL: 20130205-A 5/5/2013

Recall Number: D-408-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
318 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Sodium Chloride Injection, all strengths and all presentations including a) Bacteriostatic Sodium Chloride 0.9% 30 mL, b) Sodium Chloride 23.4% 30 mL PF, and c) Sodium Chloride 23.4% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Bacteriostatic Sodium Chloride 0.9% 30 mL, 20121205, Exp 6/11/2013; b) Sodium Chloride 23.4% 30 mL PF: 20130115-G, Exp 4/15/2013; c) Sodium Chloride 23.4% 50 mL: 20130114-E, Exp 4/14/2013

Recall Number: D-347-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
435 vials and syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 13012320-GV1, Exp 4/23/2013; 13021840GV1, Exp 5/18/2013; 13031150GV1, Exp 6/11/2013; 13021840GV1, Exp 5/18/2013; 13012320-GV1, Exp 4/23/2013; 13011532, Exp 4/15/2013.

Recall Number: D-341-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130116-A, Exp 04/16/13

Recall Number: D-367-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
227 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10 mg-10 mL, b) Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Furosemide PF-10 mg-10 mL: 20130201-F, Exp 5/1/2013; b) Furosemide PF-10 mg-2 mL SDV: 20130306-F, Exp 6/6/2013.

Recall Number: D-393-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
4350 vials and syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80 mg/5 mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# a) Methylprednisolone Acetate 40 mg/mL: 20130228-E, Exp 5/28/2013; 2013012370-GV3, Exp 4/23/2013; 20130318-D, Exp 6/18/2013; b) Methylprednisolone Acetate (PF) 40 mg/mL: 20130219-B, Exp 5/19/2013; 20130315-B, Exp 6/15/2013; c) Methylprednisolone Acetate (PF) 80 mg/mL: 201303131-A, Exp 6/13/2013; 20130304-M, Exp 6/4/2013; 20130405-A, Exp 7/5/2013; 20130214-G, Exp 5/14/2013; d) Methylpred Acetate 40 mg/mL 1 mL: 20130318-D, Exp 6/18/2013; e) Methylprednisolone 80 mg/5 mL: 20130214-G, Exp 5/14/2013

Recall Number: D-351-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
1150 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Bupivacaine and Dexamethasone Injection, all strengths and all presentations including Bupiv_Dexameth-0.25-10.5; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 13011450GV4, 13011450GV1, Exp 4/14/2013; 13011760B, Exp 4/17/2013; 13012450, Exp 4/24/2013; 13021960GV2, Exp 5/19/2013; 2013021950GV2, Exp 5/19/2013; 20130222GV3, Exp 5/22/2013; 13020450GV3, Exp 5/4/2013; 13020850GV2, Exp 5/8/2013; 13031330GV2, Exp 6/13/2013; 13032730GV1, Exp 6/27/2013; 20130327GV2, Exp 6/27/2013; 1303031475GV2, Exp 6/3/2013; 130301100GV2, Exp 6/1/2013

Recall Number: D-414-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
70 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative free 10 mL and 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Thiamine 100 mg/30 mL: 20130130-G, Exp 4/30/2013

Recall Number: D-346-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
295 vials and syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Syr, and c) Betamethasone Combo 6 mg/mL Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Beta combo: 20130123-B, Exp 4/23/201, b) Betameth_Combo_PF-6-2 Syr: 13031230GV1, Exp 6/12/2013; 13032060GV2, Exp 6/20/2013; 13011650GV7, Exp 4/16/2013; 13012330GV1, Exp 4/23/2013; 13020525Gv1, Exp 5/5/2013; c) Betamethasone Combo 6mg/ml Syr: 20130304-GV2, Exp 5/4/2013; 13031230GV1, Exp 6/12/2013

Recall Number: D-406-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
5 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Nandrolone Decanoate and Testosterone Cypionate Injection, all strengths and all presentations including a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL and b) Nandrolone 100 mg/mL TestCyp 200 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL: 130220060AE, Exp 5/20/13

Recall Number: D-401-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
70 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) 20130405-B, Exp 7/5/2013

Recall Number: D-369-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Glycerin/Lidocaine/Epinephrine Injection including Glycerin 72% Lido:Epi 2-1-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130211-U, Exp 5/11/2013

Recall Number: D-390-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
52 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 13012335-GV4, Exp 4/23/2013;; 20130226-GV2, Exp 5/26/2013; 130312200GV3, Exp 6/12/2013

Recall Number: D-361-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
98 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Edetate Disodium_150/30 mL: 20130201-E, Exp 5/2/2013; b) Edetate Disodium_150/100 mL: 20130124-B, 4/24/2013; 20130213-B, Exp 5/13/2013; 20130213-C, Exp 5/13/2013; 20130401-B, Exp 7/1/2013

Recall Number: D-364-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
48 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Estradiol Cypionate Injection, all strengths and all presentations including a) Estradiol Cypionate 5 mg/mL 10 mL and b) Estradiol Cypionate 10 mg/mL 10 ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130226-F, Exp 5/26/2013; 20130117-K, Exp 4/17/2013

Recall Number: D-340-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
78 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130319-C, Exp 06/19/13; 20130329-C, Exp 06/29/13

Recall Number: D-399-2013

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..
Initiated
04-10-2013
Reported
05-22-2013
Quantity
40 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all presentations including Phospha_Deoxy-35-30-50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 201303071500JN, Exp 6/7/2013; 1301231000AE, Exp 4/23/2013

Recall Number: D-385-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
133 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Manganese Sulfate 5 mg/5 mg, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Manganese-0.1 30 mL: 20130129500JN, Exp 4/29/2013; 1301302000AE, Exp 4/30/2013; b) Manganese Sulfate 0.1 mg/30 mL: 20130405-G, Exp 7/5/2013; c) Manganese Sulfate 5 mg/5 mL: 20130122-4, Exp 4/22/2013

Recall Number: D-383-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
197 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Magnesium Chloride Injection, all strengths and all presentations including a) Magnesium Chloride 200 mg/50 mL and b) Magnesium Chloride 200 mg/mL 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Magnesium Chloride 200 mg/50 mL: 20130321-F, Exp 6/21/2013; 20130319-I, Exp 6/19/2013; b) Magnesium Chloride 200 mg/mL 50mL: 20130307-F, Exp 6/7/2013

Recall Number: D-375-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
229 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Hydroxyprogesterone Caproate Injection, all strengths and all presentations including Hydroxyprogesterone Caproate 250 mg/mL 1 mL, 4 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : Hydroxyprogesterone Caproate 250 mg/mL 4 mL: 20130204-A, Exp 5/4/2013; 20130117-G, Exp 4/17/2013; 20130204-A, Exp 5/4/2013

Recall Number: D-356-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130122-F, Exp 4/22/2013

Recall Number: D-409-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
203 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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 .

Recall Number: D-354-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
18 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b) Calcitriol D3 10,000iu, and c) Calcitriol D3 50,000iu, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130130-A, Exp 4/30/2013

Recall Number: D-379-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
3946 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Lidocaine Injection, all strengths and all presentations including a) Lidocaine _HCl-0.5%, b) Lidocaine HCl, c) Lidocaine 1%, d) Lidocaine 1% 50 mL, e) Lidocaine 2 %, f) Lidocaine 2% 50 mL, g) Lidocaine 2% 50 mL MDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Lidocaine _HCl-0.5%: 20130403-J, 20130403-F, 20130403-H, 20130403-G, 20130403-I, Exp 7/3/2013; 2013117-I, Exp 4/17/2013; b) Lidocaine HCl: 20130131-H, Exp 4/30/2013; c) Lidocaine 1%: 20130204-N, Exp 5/4/2013; 20130115-A, Exp 4/15/2013; 20130128-E, Exp 4/28/2013; 20130220-G, Exp 5/20/2013; 20130221-J, Exp 5/21/2013; 20130221-K, Exp 5/21/2013; 20130204-J, Exp 5/4/2013; 20130315-J, Exp 6/15/2013; 20130315-K, Exp 6/15/2013; 20130328-E, Exp 6/28/2013; 20130328-H, Exp 6/28/2013; 20130328-I, Exp 6/28/2013; 20130328-K, Exp 6/28/2013; 20130329-B, Exp 6/29/2013; 20130329-C, Exp 6/29/2013; 20130304-K, Exp 6/4/2013; 20130304-L, Exp 6/4/2013; 20130305-L, Exp 6/5/2013; 20130305-D, Exp 6/5/2013; 20130306-H, Exp 6/6/2013; 20130306-P, Exp 6/6/2013; 20130307-J, Exp 6/7/2013; 20130115-B, Exp 4/15/2013; 20130201-M, Exp 5/1/2013; 20130214-A, Exp 5/14/2013; 20130204-M, Exp 5/4/2013; 20130328-F, Exp 6/28/2013; 20130329-A, Exp 6/29/2013; 20130305-M, Exp 6/5/2013; 20130305-D, Exp 6/5/2013; 20130328-J, Exp 6/28/2013; d) Lidocaine 1% 50 ml: 20130128-D, 4/28/2013; 20130115-D, Exp 4/15/2013; 20130115-F, Exp 4/15/2013; 20130117-H, Exp 4/17/2013; 20130115-C, Exp 4/15/2013; e) Lidocaine 2 %: 20130325-F, Exp 6/25/2013; 20130130-N, Exp 4/30/2013; 20130221-L, Exp 5/21/2013; 20130221-N, Exp 5/21/2013; 20130228-I, Exp 5/28/2013; 20130314-H, Exp 6/14/2013; 20130314-I, Exp 6/14/2013; 20130315-E, Exp 6/15/2013; 20130315-F, Exp 6/15/2013; 20130318-K, Exp 6/18/2013; 20130320-D, Exp 6/20/2013; 20130320-B, Exp 6/20/2013; 0130328-D, Exp 6/28/2013; 20130328-G, Exp 6/28/2013; 20130305-E, Exp 6/5/2013; 20130130-M, Exp 4/30/2013; 20130221-M, Exp 5/21/2013; 20130221-O, Exp 5/21/2013; 20130325-E, Exp 6/25/2013; f) Lidocaine 2% 50ml: 20130320-C, Exp 6/20/2013; 20130305-F, Exp 6/5/2013; 20130305-I, Exp 6/5/2013; 20130301-A, Exp 6/1/2013; 20130304-L, Exp 6/4/2013; g) Lidocaine 2% 50ml MDV: 20130227-E, Exp 5/27/2013

Recall Number: D-413-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
3727 vials and syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate Injection, all strengths and all presentations including a) Testosterone Cyp 200 mg/10 mL; b) Testosterone Cypionate 100 mg/10mL; c) Testosterone Cypionate 200 mg 10 mL; d) Testosterone Cypionate 200 mg 30 mL; e) Testosterone Cypionate 200 mg/mL; f) Testosterone Cypionate 200 mg/mL 30 mL; g) Testosterone Cypionate Sesame 200 mg/10 mL; h) Testosterone Cyp 250/30 mL; i) Testosterone Cypionate 200 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Testosterone Cyp 200 mg/10 mL: 20130128-A, Exp 4/28/2013; b) Testosterone Cypionate 100 mg/10 mL: 20130226-G, Exp 5/26/2013; 130402100AE, Exp 7/2/2013; c) Testosterone Cypionate 200 mg 10 mL: 20130220-A, Exp 5/20/2013; 20130306-L, Exp 6/6/2013; 20130221-C, Exp 5/21/2013; 20130320-A, Exp 6/20/2013; 20130403-B, Exp 7/3/2013; 20130208-A, Exp 5/8/2013; 20130215-C, Exp 5/15/2013; d) Testosterone Cypionate 200 mg 30 mL: 20130208-A, Exp 5/8/2013; 20130121-A, Exp 4/21/2013; 20130129-A, Exp 4/29/2013; 20130221-C, Exp 5/21/2013; 20130314-J, Exp 6/14/2013; 20130318-O, Exp 6/18/2013; 20130326-A, Exp 6/26/2013; 20130220-A, Exp 5/20/2013; 20130402-E, Exp 7/2/2013; e) Testosterone Cypionate 200 mg/mL: 20130304-J, Exp 6/4/2013; f) Testosterone Cypionate 200 mg/mL 30 mL: 20130215-C, Exp 5/15/2013; g) Testosterone Cypionate Sesame 200 mg/10 mL: 20130405-C, Exp 7/5/2013; h) Tetosterone Cyp 250/30 mL: 20130118-A, Exp 4/18/2013

Recall Number: D-402-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
13 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Progesterone 100 mg/mL 10 mL: 20130306-E, Exp 6/6/2013

Recall Number: D-366-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
244 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10 mg/mL 30 mL; b) Folic Acid PF 10 mg/mL 2 mL and 5 mL; c) Folic Acid 20 mg/mL 30 mL; d) Folic Acid 5 mg/mL 5 mL, 10 ml and 30 mL Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Folic Acid 10 mg/30 mL: 20130204-D, Exp 5/4/2013; b) Folic Acid PF 10mg/mL 2 mL: 20130219-E, Exp 5/15/2013

Recall Number: D-363-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
10684 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
ED Mix Injections, all strengths and all presentations including a) ED mix TM -at 2, b) ED-Mix BI-Mix 10 30 mL, c) ED-Mix BI-Mix 9 30 mL; d) ED-Mix BI-Mix-3-30, e) ED-Mix PGE 80-30, f) ED-Mix SB4 30 mL, g) Ed-Mix ST 9E, h) ED-Mix ST-1, i) ED-MIX T106, j) ED-MIX-PGE-150 30 mL, k) ED-MIX-PGE-40-30, l) ED-MIX-ST 9A, m) ED-MIX-ST 9D, n) ED-MIX-ST-9B, o) ED-MIX-T 101, p) ED-MIX-T105, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) ED mix TM -at 2: 20130306-M, Exp 6/6/2013; b) ED-Mix BI-Mix 10 30 mL: 130207120AE, Exp 5/7/2013; c) ED-Mix BI-Mix 9 30 mL: 20130121-G, Exp 4/21/2013; 20130301-F, Exp 5/1/2013; d) ED-Mix BI-Mix-3-30: 20130124-H, Exp 4/24/2013; 20130305-J, Exp 6/5/2013; e) ED-Mix PGE 80-30: 1302041000AE, Exp 5/4/2013; 20130313-B, Exp 6/13/2013; 20130322-H, Exp 6/22/2013; 20130405-I, Exp 7/5/2013; f) ED-Mix SB4 30 mL: 130304150AE, Exp 6/4/2013; g) Ed-Mix ST 9E: 2013220-C, Exp 5/20/2013; h) ED-Mix ST-1: 20130313-A, Exp 6/13/2013; 20130322-l, Exp 6/22/2013; 20120220-H, Exp 5/20/2013; 20130208-I, Exp 5/8/2013; i) ED-MIX T106: 20130322-M, Exp 6/22/2013; 20130204-L, Exp 5/4/2013; 20130313-D, Exp 6/13/2013; 20130306-R, Exp 6/6/2013; 20130401-H, Exp 7/1/2013; j) ED-MIX-PGE-150 30 mL: 20130401-J, Exp 7/1/2013; k) ED-MIX-PGE-40-30: 20130307-B, Exp 6/7/2013; 20130322-I, Exp 6/22/2013; l) ED-MIX-ST 9A: 20130401-K, Exp 7/1/2013; m) ED-MIX-ST 9D: 20130401-L, Exp 7/1/2013; n) ED-MIX-ST-9B: 20130327-A, Exp 6/27/2013; o) ED-MIX-T 101: 20130322-J, Exp 6/22/2013; 20130220-D, Exp 5/20/2013; p) ED-MIX-T105: 20130322-K, Exp 6/22/2013; 20130204-K, Exp 5/4/2013; 20130220-F, Exp 5/20/2013; 20130401-I, Exp 7/1/2013

Recall Number: D-405-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
335 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130226-GV4, Exp 5/26/2013; 13031150GV3, Exp 6/11/2013; 13031240GV4, Exp 6/12/2013; 13012325GV5, Exp 4/23/2013; 13021820GV3, Exp 5/18/2013; 13011520, Exp 4/15/2013; 13012425GV1, Exp 4/24/2013

Recall Number: D-415-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
1423 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Triamcinolone Injection, all strengths and all presentations including a) Triamcinolone 40 mg/1 mL PF, b) Triamcinolone Acetonide 45 mg/mL, c) Triamcinolone 50 mg/mL 5 mL PF, d) Triamcinolone 45 mg/mL10 mL, 30 mL, e) Triamcinolone 40 mg/mL SDV PF 1 mL, 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) Triamcinolone 40 mg/1 mL PF: 20130314-K, Exp 6/14/2013;b) Triamcinolone Acetonide 45 mg/mL: 20130129-I, Exp 4/29/2013; 20130208-B, Exp 5/8/2013; 20130314-K, Exp 6/14/2013; 20130318-E, Exp 6/18/2013; 20130308-1, Exp 6/8/2013

Recall Number: D-339-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
93 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 20130129-J, 20130129-L, Exp 04/29/13; 20130405-H, Exp 07/05/13.

Recall Number: D-392-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
19 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection, all strengths and all presentations including Lipo W/Vitamin-Carn-Crom_Glut-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : 130305600AE, Exp 6/5/2013

Recall Number: D-404-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
950 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Sodium Chloride and Dexamethasone Injection, all strengths and all presentations including a) SOD_CHLOR-DEXAMETH-0.9-10-3, b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : a) SOD_CHLOR-DEXAMETH-0.9-10-3: 13011450GV3, Exp 4/14/2013; 13011450GV2, Exp 4/14/2013; 13011760A, Exp 4/17/2013; 13012440, Exp 4/24/2013; 13020425GV2, Exp 5/4/2013; 2013021950GV1, Exp 5/19/2013; b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3: 13031330GV1, Exp 6/13/2013; 13031460GV1, Exp 6/14/2013; 13032740GV2, Exp 6/27/2013; 20130327GV1, Exp 6/27/2013; 13021920GV1, Exp 5/19/2013; 130301100GV3, Exp 6/1/2013; 20130222GV2, Exp 5/22/2013; 13020850GV1, Exp 5/8/2013

Recall Number: D-407-2013

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.
Initiated
04-10-2013
Reported
05-22-2013
Quantity
6213 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FVS Holdings, Inc. dba. Green Valley Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Sodium Bicarbonate Injection, all strengths and all presentations including: a) Sodium Bicarb 4.2% 5 mL PF, b) Sodium Bicarb 8.4% 50 mL SDV, c) Sodium Bicarbonate 8.4%, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Batch or Lot Expiration Information

Lot# : Sodium Bicarb 4.2% 5 mL PF: 130123150AE, Exp 4/23/2013; b) Sodium Bicarb 8.4% 50 mL SDV: 20130315-L, Exp 6/15/2013; c) Sodium Bicarbonate 8.4%: 20130117-D, Exp 4/17/2013; 20130117-E, Exp 4/17/2013; 20130117-F, Exp 4/17/2013; 20130121-B, Exp 4/21/2013; 20130121-C, Exp 4/21/2013; 20130121-D, Exp 4/21/2013; 20130121-E, Exp 4/21/2013; 20130121-F, Exp 4/21/2013; 20130121-H, Exp 4/21/2013; 20130121-I, Exp 4/21/2013; 20130121-J, Exp 4/21/2013; 20130121-K, Exp 4/21/2013; 20130124-D, Exp 4/24/2013; 20130124-E, Exp 4/24/2013; 20130129-B, Exp 4/29/2013; 20130129-C, Exp 4/29/2013; 20130129-D, Exp 4/29/2013; 20130129-K, Exp 4/29/2013; 20130129-L, Exp 4/29/2013; 20130129-M, Exp 4/29/2013; 20130131-I, Exp 4/30/2013; 20130131-J, Exp 4/30/2013; 20130131-K, Exp 4/30/2013; 20130201-B, Exp 5/1/2013; 20130201-C, Exp 5/1/2013; 20130211-A, Exp 5/11/2013; 20130211-B, Exp 5/11/2013; 20130211-C, Exp 5/11/2013; 20130211-D, Exp 5/11/2013; 20130211-E, Exp 5/11/2013; 20130211-F, Exp 5/11/2013; 20130211-G, Exp 5/11/2013; 20130211-H, Exp 5/11/2013; 20130211-I, Exp 5/11/2013; 20130211-J, Exp 5/11/2013; 20130211-K, Exp 5/11/2013; 20130211-L, Exp 5/11/2013; 20130211-N, Exp 5/11/2013; 20130211-O, Exp 5/11/2013; 20130211-P, Exp 5/11/2013; 20130211-Q, Exp 5/11/2013; 20130211-R, Exp 5/11/2013; 20130211-S, Exp 5/11/2013; 20130211-T, Exp 5/11/2013; 20130214-D, Exp 5/14/2013; 20130214-E, Exp 5/14/2013; 20130214-H, Exp 5/14/2013; 20130215-A, Exp 5/15/2013; 20130215-B, Exp 5/15/2013; 20130215-D, Exp 5/15/2013; 20130215-E, Exp 5/15/2013; 20130215-G, Exp 5/15/2013; 20130215-H, Exp 5/15/2013; 13021840GV3, Exp 5/18/2013; 20130219-G, Exp 5/19/2013; 20130219-H, Exp 5/19/2013; 20130219-I, Exp 5/19/2013; 20130219-J, Exp 5/19/2013; 20130221-B, Exp 5/21/2013; 20130221-A, Exp 5/21/2013; 20130221-E, Exp 5/21/2013; 20130221-F, Exp 5/21/2013; 20130221-G, Exp 5/21/2013; 20130221-H, Exp 5/21/2013; 20130221-P, Exp 5/21/2013; 20130221-Q, Exp 5/21/2013; 20130221-S, Exp 5/21/2013; 20130222-B, Exp 5/22/2013; 20130222-C, Exp 5/22/2013; 20130225-E, Exp 5/25/2013; 20130225-F, Exp 5/25/2013; 20130225-G, Exp 5/25/2013; 201302256-GV4, Exp 5/25/2013; 20130227-P, Exp 5/27/2013; 20130227-Q, Exp 5/27/2013; 20130227-R, Exp 5/27/2013; 20130227-S, Exp 5/27/2013; 20130227-T, Exp 5/27/2013; 20130228-F, Exp 5/28/2013; 20130228-G, Exp 5/28/2013; 20130204-I, Exp 5/4/2013; 20130205-D, Exp 5/5/2013; 20130205-E, Exp 5/5/2013; 20130205-F, Exp 5/5/2013; 20130206-E, Exp 5/6/2013; 20130206-F, Exp 5/6/2013; 20130206-I, Exp 5/6/2013; 20130206-J, Exp 5/6/2013; 20130206-K, Exp 5/6/2013; 20130206-L, Exp 5/6/2013; 20130207-C, Exp 5/7/2013; 20130207-D, Exp 5/7/2013; 20130207-E, Exp 5/7/2013; 20130301-B, Exp 6/1/2013; 20130312-A, Exp 6/12/2013; 20130312-B, Exp 6/12/2013; 20130312-C, Exp 6/12/2013; 20130312-D, Exp 6/12/2013; 13031240GV4, Exp 6/12/2013; 20130313-J, Exp 6/13/2013; 20130313-K, Exp 6/13/2013; 20130314-G, Exp 6/14/2013; 20130314-L, Exp 6/14/2013; 20130314-M, Exp 6/14/2013; 20130315-L, Exp 6/15/2013; 20130315-M, Exp 6/15/2013; 20130315-N, Exp 6/15/2013; 20130318-H, Exp 6/18/2013; 20130319-D, Exp 6/19/2013; 20130319-K, Exp 6/19/2013; 20130319-L, Exp 6/19/2013; 20130320-G, Exp 6/20/2013; 20130320-H, Exp 6/20/2013; 20130320-I, Exp 6/20/2013; 20130320-J, Exp 6/20/2013; 20130320-K, Exp 6/20/2013; 20130320-L, Exp 6/20/2013; 20130325-I, Exp 6/25/2013; 20130325-J, Exp 6/25/2013; 20130325-L, Exp 6/25/2013; 20130325-M, Exp 6/25/2013; 20130325-N, Exp 6/25/2013; 20130327-D, Exp 6/27/2013; 20130327-E, Exp 6/27/2013; 20130327-F, Exp 6/27/2013; 20130327-G, Exp 6/27/2013; 20130327-H, Exp 6/27/2013; 20130327-I, Exp 6/27/2013; 20130327-J, Exp 6/27/2013; 20130327-K, Exp 6/27/2013; 20130327-L, Exp 6/27/2013; 20130327-M, Exp 6/27/2013; 20130327-N, Exp 6/27/2013; 20130329-D, Exp 6/29/2013; 20130329-E, Exp 6/29/2013; 20130329-F, Exp 6/29/2013; 20130329-G, Exp 6/29/2013; 20130304-B, Exp 6/4/2013; 20130304-C, Exp 6/4/2013; 20130304-D, Exp 6/4/2013; 20130304-E, Exp 6/4/2013; 20130304-F, Exp 6/4/2013; 20130304-G, Exp 6/4/2013; 20130304-H, Exp 6/4/2013; 20130304-I, Exp 6/4/2013; 20130306-A, Exp 6/6/2013; 20130306-B, Exp 6/6/2013; 20130306-C, Exp 6/6/2013; 20130306-D, Exp 6/6/2013; 20130306-I, Exp 6/6/2013; 20130306-J, Exp 6/6/2013; 20130306-K, Exp 6/6/2013; 20130308-A, Exp 6/8/2013; 20130308-B, Exp 6/8/2013; 20130308-C, Exp 6/8/2013; 20130308-D, Exp 6/8/2013; 20130308-E, Exp 6/8/2013; 20130308-F, Exp 6/8/2013; 20130401-D, Exp 7/1/2013; 20130401-E, Exp 7/1/2013; 20130401-F, Exp 7/1/2013; 20130404-B, Exp 7/4/2013; 20130404-C, Exp 7/4/2013