FDAClass IMay 28, 2014

Acetylcysteine Solution recall: Particulate Matter

Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02

Why was Acetylcysteine Solution recalled?

Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution

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?

2005479, Exp 03/14

Product
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
Recalling firm
Ben Venue Laboratories Inc
Quantity
5,131 vials
Distribution
Nationwide.
Recall date
May 28, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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