FDAClass IIIJune 6, 2018

Hydrocodone Bitartrate and Acetaminophen Tablets recall: Labeling Error

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ…

Why was Hydrocodone Bitartrate and Acetaminophen Tablets recalled?

Labeling: Missing 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 # S800257; Exp. 01/20

Product
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ…
Recalling firm
LUPIN SOMERSET
Quantity
1,672 (1000-count) bottles
Distribution
OH
Recall date
June 6, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls