Home / Recalls / FVS Holdings, Inc. dba. Green Valley Drugs / D-384-2013

D-384-2013 Class II Terminated

Recalled by FVS Holdings, Inc. dba. Green Valley Drugs — Henderson, NV

Recall Details

Product Type
Drugs
Report Date
May 22, 2013
Initiation Date
April 10, 2013
Termination Date
March 21, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
529 vials

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Distribution Pattern

Nationwide

Code Information

Lot #: a) 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

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  • D-391-2013 Class II — Methylprednisolone, Lidocaine, and Sodium Chloride Injection, all strengths and (April 10, 2013)
  • D-350-2013 Class II — Biotin Injection, all strengths and all presentations including Biotin-15-30 mL, (April 10, 2013)
  • D-381-2013 Class II — Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all (April 10, 2013)
  • D-380-2013 Class II — Lipotropic With Vitamin Injections, all strengths and all presentations includin (April 10, 2013)
  • D-349-2013 Class II — Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all (April 10, 2013)
  • D-342-2013 Class II — Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg (April 10, 2013)
  • D-410-2013 Class II — Testosterone Cypionate and Testosterone Propionate Injection, all strengths and (April 10, 2013)
  • D-358-2013 Class II — Dexpanthenol Injection, all strengths and all presentations including Dexpanthen (April 10, 2013)