FDAClass IIIFebruary 21, 2018

NORCO (Hydrocodone Bitartrate and Acetaminophen) recall: Labeling Error

NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.

Why was NORCO (Hydrocodone Bitartrate and Acetaminophen) recalled?

Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.

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 # 544821A, Exp 07/19

Product
NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
Recalling firm
ALLERGAN
Quantity
8 bottles
Distribution
Nationwide in the USA
Recall date
February 21, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls