Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Carbamazepine Oral Suspension Recalled by Precision Dose Inc. Due to Labeling Error: Label mix-up. Products' unit dose cups...

Date: July 5, 2017
Company: Precision Dose Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Precision Dose Inc. directly.

Affected Products

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.

Quantity: 480 (5mL) unit dose cups

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 2 states: CT, OH

Affected (2 states)Not affected

About Precision Dose Inc.

Precision Dose Inc. has 7 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report