D-362-2013 Class II Terminated
FDA drug recall D-362-2013 was initiated by FVS Holdings, Inc. dba. Green Valley Drugs on April 10, 2013 and is designated Class II. 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 co… The recall status is terminated (terminated March 21, 2014). Affected quantity: 227 vials.
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
- 227 vials
Product Description
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.
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) 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