FDAClass IIAugust 9, 2017

Carbamazepine Oral Suspension recall: Labeling Error

Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.

Why was Carbamazepine Oral Suspension recalled?

Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.

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 #: 500326, Exp. 6/30/2018

Product
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
Recalling firm
Precision Dose Inc.
Quantity
480 (5mL) unit dose cups
Distribution
OH and CT
Recall date
August 9, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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