FDAClass IIISeptember 20, 2017

Hydrocodone Bitartrate and Acetaminophen Oral Solution recall: Labeling Error

Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by…

Why was Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled?

Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance

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: 494700 Exp. 10/2018

Product
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by…
Recalling firm
VistaPharm, Inc.
Quantity
3084 bottles
Distribution
Nationwide
Recall date
September 20, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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