D-372-2013 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
63 vials

Product Description

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.

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