FDAClass IIMay 22, 2013

Ascorbic Acid Injection recall: Sterility Concern

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…

Why was Ascorbic Acid Injection recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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…
Recalling firm
FVS Holdings, Inc. dba. Green Valley Drugs
Quantity
2682 vials
Distribution
Nationwide
Recall date
May 22, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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