FDAClass IOctober 15, 2014

N-Acetyl Cysteine 20% recall: Sterility Concern

N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133

Why was N-Acetyl Cysteine 20% recalled?

Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.

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 #: 86513, Exp 07/23/2014

Product
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Recalling firm
Unique Pharmaceutical, Ltd
Quantity
3,529 Vials
Distribution
Nationwide
Recall date
October 15, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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