PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: August 9, 2017 Initiated: July 5, 2017 #D-1037-2017

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Precision Dose Inc.
Units Affected
480 (5mL) unit dose cups
Distribution
OH and CT
Location
South Beloit, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Precision Dose Inc.. Units affected: 480 (5mL) unit dose cups.
Why was this product recalled?
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 9, 2017. Severity: Moderate. Recall number: D-1037-2017.